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Comparison of topical hydrocortisone versus dexamethasone treatment for inflammatory secretions of the conjunctiva in patients with ocular prostheses
EU CTIS ID: 2024-517441-14-00
What this study is testing
To study the efficacy of two topical molecules on the secretions of patients with prostheses: Hydrocortisone and Dexamethasone versus a tear substitute, DULCILARMES®, which will serve as a comparator.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged 18 years or older
- Wearing a permanent prosthesis for more than 6 months
- Modified OSDI score ≥ 13 points out of 40 ;
- Affiliated to a health insurance scheme,
- Having given free, informed and written consent.
- Consultant in the ophthalmology department
You likely can't join if
- Treatment with eye drops (other than artificial tears or antiseptic) < 1 month
- Fatty dermal graft or complicated cavity
- Gougerot-Sjögren syndrome
- Allergic conjunctivitis
- Damaged prosthesis
- Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability)
See the full eligibility criteria
- Patient aged 18 years or older
- Wearing a permanent prosthesis for more than 6 months
- Modified OSDI score ≥ 13 points out of 40 ;
- Affiliated to a health insurance scheme,
- Having given free, informed and written consent.
- Consultant in the ophthalmology department
- Treatment with eye drops (other than artificial tears or antiseptic) < 1 month
- Fatty dermal graft or complicated cavity
- Gougerot-Sjögren syndrome
- Allergic conjunctivitis
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.