Dry EyePhase 4NCT03907865
Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
A Phase 4 study testing Softacort in people with Dry Eye, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Softacort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 27 Mar 2018to 2 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Normal ophthalmic findings except dry eye disease
- Ametropy ≤ 6 diopters
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI ≥ 22
- Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
- Current use of topical lubricants since at least 3 months
Who cannot join
- Best far corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- Eyelid malposition
- Sjogren Syndrome
- Steven Johnson Syndrome
- Corneal dystrophy
Show all 38Show fewer
- Ocular neoplasia
- Filamentous keratitis
- Corneal neovascularisation
- Orbital radiotherapy
- History of any of the following within last 3 months:
- Systemic treatment of dry eye
- Systemic treatment of MGD
- Isotretinoide,
- Cyclosporine,
- Tacrolimus, Siromilus, Pimecrolimus
- Punctual plugs
- Anti-glaucoma treatment
- History of any of the following within previous six months:
- ocular trauma
- ocular infection, ocular allergy
- History of any of the following within last 12 months:
- inflammatory corneal ulcer
- Herpetic eye infection or uveitis
- Ocular surgery
- History of IOP increase caused by systemic or topical treatment with corticosteroids
- IOP > 22mmHg
- Glaucoma in the medical history
- Known hypersensitivity to any of the components of the IMP under investigation or other study medication
- Allergic rhinitis; active or susceptible to reactivation during the study
- Pregnant or breast-feeding woman.
- Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intrauterine device, contraceptive implant or condoms)
- Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
- Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- Participation in another clinical study or clinical investigation at the same time as the present investigation
- Participation to the present clinical investigation during the exclusion period of another clinical study
- Patient already included once in this clinical investigation
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University Vienna
Vienna, 1090
About this study
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.
- Conditions
- Dry Eye
- Being tested
- Softacort
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftacortDrug
Group 1: 4 times daily for the first 12 days of the treatment period and then 2 times daily for 2 additional days Group 2: 3 times daily for the first 8 days of the treatment period and then 2 times daily for 3 additional days
| Study group | Role | What they receive |
|---|---|---|
| intense | Experimental | Patients have been randomized to receive Softacort eye drops for 12 days 4 times daily followed by 2 days twice daily treatment resulting in a total time of 14 days Receives: Drug: Softacort |
| standard | Experimental | Patients have been randomized to receive Softacort eye drops for 8 days 3 times daily followed by 3 days twice daily treatment resulting in a treatment time of 11 days total Receives: Drug: Softacort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival hyperemia
Conjunctival hyperemia will be graded according to the Efron Scale: 0=none, 1=trace, 2 = mild, 3 = moderate, 4 = severe
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start27 Mar 2018
- Primary completion28 Nov 2018
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907865
- Sponsor's protocol ID
- T1565-PIV-0117
- Status last verified
- Aug 2019
- First submitted
- 5 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial. Adv Ther. 2020 Jan;37(1):329-341. doi: 10.1007/s12325-019-01137-8. Epub 2019 Nov 18.
PubMed 31741283
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
- ClinicalTrials.gov ID
- NCT03907865
- Acronym / sponsor ID
- T1565-PIV-0117
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 9 Apr 2019 (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.
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intense | Experimental | Drug: SoftacortPatients have been randomized to receive Softacort eye drops for 12 days 4 times daily followed by 2 days twice daily treatment resulting in a total time of 14 days |
| standard | Experimental | Drug: SoftacortPatients have been randomized to receive Softacort eye drops for 8 days 3 times daily followed by 3 days twice daily treatment resulting in a treatment time of 11 days total |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Normal ophthalmic findings except dry eye disease
- Ametropy ≤ 6 diopters
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI ≥ 22
Key exclusion criteria (38 listed)
- Best far corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- Eyelid malposition
- Sjogren Syndrome
- Steven Johnson 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 |
|---|---|---|
| SoftacortGroup 1: 4 times daily for the first 12 days of the treatment period and then 2 times daily for 2 additional days Group 2: 3 times daily for the first 8 days of the treatment period and then 2 times daily for 3 additional days | Drug | intense, standard |
Primary outcome
Conjunctival hyperemia
Time frame: 5 minutes
Conjunctival hyperemia will be graded according to the Efron Scale: 0=none, 1=trace, 2 = mild, 3 = moderate, 4 = severe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 31741283Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial. Adv Ther. 2020 Jan;37(1):329-341. doi: 10.1007/s12325-019-01137-8. Epub 2019 Nov 18.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Softacort in people with Dry Eye, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 38 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 Austria. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival hyperemia (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907865, which also lists 1 linked publication.
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 13 Aug 2019.