Comparing treatments for inflammation in patients with eye prostheses
Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
This study is testing whether Hydrocortisone or Dexamethasone can help reduce inflammation and discomfort in people who wear eye prostheses.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT05668455 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Hydrocortisone and Dexamethasone in treating ocular inflammation in patients who wear ocular prostheses. It will utilize a prospective, placebo-controlled, single-blind design to assess the impact of these anti-inflammatory treatments on patients experiencing significant discomfort. The study builds on previous findings from a pilot study that suggested Dexamethasone may be beneficial, but seeks to provide more rigorous evidence through a controlled methodology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been wearing a permanent ocular prosthesis for more than six months and experience significant functional discomfort.
Not a fit: Patients who have recently used other eye drops or have specific contraindications to the study treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients with ocular prostheses by reducing inflammation and discomfort.
How similar studies have performed: Previous studies have shown some promise with Dexamethasone in similar patient populations, but this study aims to provide more definitive evidence through a controlled approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rennes
- Centre Hospitalier Universitaire de Rennes _ Pontchaillou — Rennes, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.