Dry Eye SyndromesTREDIANCT06174181
Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration
A study testing Preservative-free ophtalmic lubricant emulsion and Routine treatment in people with Dry Eye Syndromes and Age-Related Macular Degeneration, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
Trial summary
Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Age-Related Macular Degeneration
- What is being tested?
- Preservative-free ophtalmic lubricant emulsion and Routine treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Oct 2023to 14 Nov 2024
- Phase
- Interventional
- 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
- Adult patient treated for exudative AMD with at least one eye receiving IVI with an anti-VEGF for at least 12 months.
- Patient with at least one untreated dry eye symptom.
- Only one eye is included per patient. For patients injected bilaterally, the eye with the lowest TBUT will be included, otherwise the one with the highest Oxford score, otherwise the one with the lowest Schirmer score. If these 3 parameters are similar, the right eye will be included by default.
- Patient who has given informed consent to participate and understands the information related to the study.
- Patient affiliated with a social security plan or beneficiary of such a plan.
- Concurrent participation in non-interventional research is allowed. Concurrent participation in interventional research may be evaluated on a case-by-case basis by the Principal Investigator.
Who cannot join
- Patients with meatus plugs at inclusion.
- Eye surgery ≤ 3 months pre-inclusion (including laser or refractive).
- Anticholinergic* treatment prior to inclusion.
- Patients unable to maintain follow-up during the study period.
- Evidence of active ocular infection in either eye.
- History or presence of non-drying ocular surface disorders in either eye.
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- Trauma or surgery to the eyelids.
- Any ocular or systemic pathology or treatment identified by the Investigator as likely to interfere with the results of the study.
- Hypersensitivity to any component of the medical device.
Trial locations and contacts
2 sites in 1 country.
About this study
Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.
- Being tested
- Preservative-free ophtalmic lubricant emulsion, Routine treatment
- Medical subject headings
- Dry Eye Syndromes, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative-free ophtalmic lubricant emulsionDevice
Use of a preservative-free ophtalmic lubricant emulsion continous during 6 months
Routine treatmentOther
Use of a preservative-free ophtalmic lubricant emulsion after each intravitreal injection during few days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Preservative-free ophtalmic lubricant emulsion countinuous during 6 month after intravitreal Injections for Age-related macular degeneration Receives: Device: Preservative-free ophtalmic lubricant emulsion |
| Routine treatment | Other | Preservative-free ophtalmic lubricant emulsion during few days after intravitreal Injections for Age-related macular degeneration Receives: Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean tear break-up time (TBUT) at the end of the study
Mean tear break-up time (TBUT) in seconds at the last study assessment. This is the standard measurement performed in routine care, which reduces the probability of missing data
Measured: 24 weeks
Secondary outcomes (1)
ocular surface alteration after 24 weeks
Ocular Staining Score d'Oxford
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start9 Oct 2023
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
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 Eye SyndromesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174181
- Sponsor's protocol ID
- 2022PPRC11
- Other IDs
- 2023-A00620-45
- Acronym
- TREDIA
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torres-Villaros H, Giocanti-Auregan A, Doan S, Agard E, Billant J, Arbousoff N, Matagrin B, Fenniri I, Dot C. Continuous versus Intermittent Use of Tear Substitutes in Patients Treated with Anti-VEGF for Neovascular Age-Related Macular Degeneration: The TREDIA Study. Ophthalmol Ther. 2025 Sep;14(9):2231-2241. doi: 10.1007/s40123-025-01201-3. Epub 2025 Jul 22.
PubMed 40691408
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06174181
- Acronym / sponsor ID
- TREDIA / 2022PPRC11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 18 Dec 2023 (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.
Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Preservative-free ophtalmic lubricant emulsionPreservative-free ophtalmic lubricant emulsion countinuous during 6 month after intravitreal Injections for Age-related macular degeneration |
| Routine treatment | Other | Other: Routine treatmentPreservative-free ophtalmic lubricant emulsion during few days after intravitreal Injections for Age-related macular degeneration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient treated for exudative AMD with at least one eye receiving IVI with an anti-VEGF for at least 12 months.
- Patient with at least one untreated dry eye symptom.
- Only one eye is included per patient. For patients injected bilaterally, the eye with the lowest TBUT will be included, otherwise the one with the highest Oxford score, otherwise the one with the lowest Schirmer score. If these 3 parameters are similar, the right eye will be included by default.
- Patient who has given informed consent to participate and understands the information related to the study.
- Patient affiliated with a social security plan or beneficiary of such a plan.
Key exclusion criteria (9 listed)
- Patients with meatus plugs at inclusion.
- Eye surgery ≤ 3 months pre-inclusion (including laser or refractive).
- Anticholinergic* treatment prior to inclusion.
- Patients unable to maintain follow-up during the study period.
- Evidence of active ocular infection in either eye.
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 |
|---|---|---|
| Preservative-free ophtalmic lubricant emulsionUse of a preservative-free ophtalmic lubricant emulsion continous during 6 months | Device | Experimental |
| Routine treatmentUse of a preservative-free ophtalmic lubricant emulsion after each intravitreal injection during few days | Other | Routine treatment |
Primary outcome
Mean tear break-up time (TBUT) at the end of the study
Time frame: 24 weeks
Mean tear break-up time (TBUT) in seconds at the last study assessment. This is the standard measurement performed in routine care, which reduces the probability of missing data
1 secondary outcome
ocular surface alteration after 24 weeks
Time frame: 24 weeks
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 25 Feb 2025.
- Derived from this study: PubMed 40691408Torres-Villaros H, Giocanti-Auregan A, Doan S, Agard E, Billant J, Arbousoff N, Matagrin B, Fenniri I, Dot C. Continuous versus Intermittent Use of Tear Substitutes in Patients Treated with Anti-VEGF for Neovascular Age-Related Macular Degeneration: The TREDIA Study. Ophthalmol Ther. 2025 Sep;14(9):2231-2241. doi: 10.1007/s40123-025-01201-3. Epub 2025 Jul 22.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservative-free ophtalmic lubricant emulsion and Routine treatment in people with Dry Eye Syndromes and Age-Related Macular Degeneration, run by Direction Centrale du Service de Santé des Armées at 2 sites 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 9 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mean tear break-up time (TBUT) at the end of the study (time frame: 24 weeks). 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 NCT06174181, 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 25 Feb 2025.