Ocular InflammationPhase 3CRYSTALNCT05668455
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
A Phase 3 study testing Hydrocortisone, Dexamethasone and Povidone in people with Ocular Inflammation and Ocular Prostheses, run by Agnes at 1 site in France.
Trial summary
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ocular Inflammation, Ocular Prostheses
- What is being tested?
- Hydrocortisone, Dexamethasone and Povidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2023to 20 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older;
- Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
- Modified OSDI score ≥ 20 points out of 40 ;
- Affiliated with a health insurance scheme,
- For women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate <1%, for the duration of the study and up to 1 week after the last dose administered)
- Have given free, informed and written consent.
Who cannot join
- Treatment with eye drop(s) (other than artificial tears or antiseptic) < 1 month;
- Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
- Known contraindications to study treatments
- Dermal fat grafting or complicated cavity;
- Gougerot-Sjögren syndrome;
- Allergic conjunctivitis;
Show all 11Show fewer
- Damaged prosthesis;
- Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability);
- Pregnant or breastfeeding woman;
- Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study
- Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Rennes, 35000
Frederic MOURIAUX, MD, frederic.mouriaux@chu-rennes.fr
Yann MAUCOURANT, MD, yann.maucourant@chu-rennes.fr
About this study
Official title: Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
Read the detailed description
There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis.
A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled.
We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses.
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
- Conditions
- Ocular Inflammation, Ocular Prostheses
- Being tested
- Hydrocortisone, Dexamethasone, Povidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
1 drops 4 times a day
DexamethasoneDrug
1 drops 4 times a day
PovidoneOther
1 drops 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| HYDROCORTISONE | Experimental | Topical corticosteroid : hydrocortisone Receives: Drug: Hydrocortisone |
| DEXAMETHASONE | Experimental | Topical corticosteroid : dexamethasone Receives: Drug: Dexamethasone |
| POVIDONE | Placebo comparator | Topical : tear substitute Receives: Other: Povidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40 point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: Before first treatment period of 14 days
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: After first treatment period of 14 days
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: At 2 months (After second treatment period of 14 days)
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: At 3 months (1 Month Wash-out after second treatment, and before third treatment)
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints.
This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points.
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Measured: At 3.5 months (After third treatment period of 14 days)
Secondary outcomes (38)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Measured: At inclusion visit (basal)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Measured: After first treatment period of 14 days
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Measured: At 2 months (After second treatment period of 14 days)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Measured: At 3.5 months (After third treatment period of 14 days)
Tarsal conjunctival inflammation score according
Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)
Measured: At inclusion visit (basal)
Tarsal conjunctival inflammation score according
Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)
Measured: After first treatment period of 14 days
Tarsal conjunctival inflammation score according
Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)
Measured: At 2 months (After second treatment period of 14 days)
Tarsal conjunctival inflammation score according
Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)
Measured: At 3.5 months (After third treatment period of 14 days)
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: Before first treatment period of 14 days
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: After first treatment period of 14 days
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: At 1.5 month (Before second treatment period of 14 days
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: At 2 months (After second treatment period of 14 days
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3 months (Before third treatment period of 14 days)
Secretion frequency
Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3.5 months (After third treatment period of 14 days)
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: Before first treatment period of 14 days
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: After first treatment period of 14 days
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: At 1.5 month (Before second treatment period of 14 days)
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: At 2 months (After second treatment period of 14 days
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3 months (Before third treatment period of 14 days)
Colour of secretions
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3.5 months (After third treatment period of 14 days)
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: Before first treatment period of 14 days
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: After first treatment period of 14 days
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: At 1.5 month (Before second treatment period of 14 days)
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: At 2 months (After second treatment period of 14 days
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3 months (Before third treatment period of 14 days
Amount of secretions
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Measured: At 3.5 months (After third treatment period of 14 days)
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: Before first treatment period of 14 days
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: After first treatment period of 14 days
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: At 1.5 month (Before second treatment period of 14 days)
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: At 2 months (After second treatment period of 14 days
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: At 3 months (Before third treatment period of 14 days)
Thickness/Viscosity of secretions
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Measured: At 3.5 months (After third treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: Before first treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: After first treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: At 1.5 month (Before second treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: At 2 months (After second treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: At 3 months (Before third treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
Measured: At 3.5 months (After third treatment period of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start12 May 2023
- Primary completion25 Dec 2025 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, single-centre, controlled, randomised, single-blind, cross-over clinical study with 2 treatments and an artificial tear. (First treatment (14 days) and Wash out (1month) / Second treatment treatment (14 days) and Wash out (1month) /Third treatment (14 days) and Wash out (1month)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agnes
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Laboratoires Thea
- Responsible party
- Sponsor-investigator, Agnes, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668455
- Sponsor's protocol ID
- 35RC21_8901_CRYSTAL
- Acronym
- CRYSTAL
- Status last verified
- Aug 2025
- First submitted
- 3 Oct 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
- ClinicalTrials.gov ID
- NCT05668455
- Acronym / sponsor ID
- CRYSTAL / 35RC21_8901_CRYSTAL
- Conditions
- Ocular Inflammation, Ocular Prostheses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AgnesUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Laboratoires Thea
- Study start
- 12 May 2023 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
Detailed description
There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis.
A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled.
We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses.
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective, single-centre, controlled, randomised, single-blind, cross-over clinical study with 2 treatments and an artificial tear. (First treatment (14 days) and Wash out (1month) / Second treatment treatment (14 days) and Wash out (1month) /Third treatment (14 days) and Wash out (1month)
| Arm | Type | Receives |
|---|---|---|
| HYDROCORTISONE | Experimental | Drug: HydrocortisoneTopical corticosteroid : hydrocortisone |
| DEXAMETHASONE | Experimental | Drug: DexamethasoneTopical corticosteroid : dexamethasone |
| POVIDONE | Placebo comparator | Other: PovidoneTopical : tear substitute |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 years or older;
- Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
- Modified OSDI score ≥ 20 points out of 40 ;
- Affiliated with a health insurance scheme,
- For women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate <1%, for the duration of the study and up to 1 week after the last dose administered)
Key exclusion criteria (11 listed)
- Treatment with eye drop(s) (other than artificial tears or antiseptic) < 1 month;
- Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
- Known contraindications to study treatments
- Dermal fat grafting or complicated cavity;
- Gougerot-Sjögren syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone1 drops 4 times a day | Drug | HYDROCORTISONE |
| Dexamethasone1 drops 4 times a day | Drug | DEXAMETHASONE |
| Povidone1 drops 4 times a day | Other | POVIDONE |
Primary outcome
Secretion Self-Rating Analog Scale score.
Time frame: Before first treatment period of 14 days
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40 point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Secretion Self-Rating Analog Scale score.
Time frame: After first treatment period of 14 days
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Secretion Self-Rating Analog Scale score.
Time frame: At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Secretion Self-Rating Analog Scale score.
Time frame: At 2 months (After second treatment period of 14 days)
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Secretion Self-Rating Analog Scale score.
Time frame: At 3 months (1 Month Wash-out after second treatment, and before third treatment)
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Secretion Self-Rating Analog Scale score.
Time frame: At 3.5 months (After third treatment period of 14 days)
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
38 secondary outcomes
Bulbar conjunctival inflammation score
Time frame: At inclusion visit (basal)
Bulbar conjunctival inflammation score
Time frame: After first treatment period of 14 days
Bulbar conjunctival inflammation score
Time frame: At 2 months (After second treatment period of 14 days)
Bulbar conjunctival inflammation score
Time frame: At 3.5 months (After third treatment period of 14 days)
Tarsal conjunctival inflammation score according
Time frame: At inclusion visit (basal)
Tarsal conjunctival inflammation score according
Time frame: After first treatment period of 14 days
Tarsal conjunctival inflammation score according
Time frame: At 2 months (After second treatment period of 14 days)
Tarsal conjunctival inflammation score according
Time frame: At 3.5 months (After third treatment period of 14 days)
Secretion frequency
Time frame: Before first treatment period of 14 days
Secretion frequency
Time frame: After first treatment period of 14 days
Secretion frequency
Time frame: At 1.5 month (Before second treatment period of 14 days
Secretion frequency
Time frame: At 2 months (After second treatment period of 14 days
Secretion frequency
Time frame: At 3 months (Before third treatment period of 14 days)
Secretion frequency
Time frame: At 3.5 months (After third treatment period of 14 days)
Colour of secretions
Time frame: Before first treatment period of 14 days
Colour of secretions
Time frame: After first treatment period of 14 days
Colour of secretions
Time frame: At 1.5 month (Before second treatment period of 14 days)
Colour of secretions
Time frame: At 2 months (After second treatment period of 14 days
Colour of secretions
Time frame: At 3 months (Before third treatment period of 14 days)
Colour of secretions
Time frame: At 3.5 months (After third treatment period of 14 days)
Amount of secretions
Time frame: Before first treatment period of 14 days
Amount of secretions
Time frame: After first treatment period of 14 days
Amount of secretions
Time frame: At 1.5 month (Before second treatment period of 14 days)
Amount of secretions
Time frame: At 2 months (After second treatment period of 14 days
Amount of secretions
Time frame: At 3 months (Before third treatment period of 14 days
Amount of secretions
Time frame: At 3.5 months (After third treatment period of 14 days)
Thickness/Viscosity of secretions
Time frame: Before first treatment period of 14 days
Thickness/Viscosity of secretions
Time frame: After first treatment period of 14 days
Thickness/Viscosity of secretions
Time frame: At 1.5 month (Before second treatment period of 14 days)
Thickness/Viscosity of secretions
Time frame: At 2 months (After second treatment period of 14 days
Thickness/Viscosity of secretions
Time frame: At 3 months (Before third treatment period of 14 days)
Thickness/Viscosity of secretions
Time frame: At 3.5 months (After third treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
Time frame: Before first treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
Time frame: After first treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
Time frame: At 1.5 month (Before second treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
Time frame: At 2 months (After second treatment period of 14 days
OSDI quality of life score adapted to prosthesis wearers
Time frame: At 3 months (Before third treatment period of 14 days)
OSDI quality of life score adapted to prosthesis wearers
Time frame: At 3.5 months (After third treatment period of 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Rennes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone, Dexamethasone and Povidone in people with Ocular Inflammation and Ocular Prostheses, run by Agnes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secretion Self-Rating Analog Scale score. (time frame: Before first treatment period of 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.