Clinical Trials in France / NCT05668455
Recruiting
Phase 3
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
NCT05668455 · tracked via the Priya Life Science France tracker
Condition(s) studied
Ocular InflammationOcular Prostheses
Investigational drug(s) / intervention(s)
Hydrocortisone: 1 drops 4 times a day
Dexamethasone: 1 drops 4 times a day
Povidone: 1 drops 4 times a day
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Primary outcome measure(s)
- Secretion Self-Rating Analog Scale score. — 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. — 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. — 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. — 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. — 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. — 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)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Rennes _ Pontchaillou | Rennes | France | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05668455 on ClinicalTrials.gov ↗ ← All trials in France