Status:

RECRUITING

Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)

Lead Sponsor:

Agnes

Collaborating Sponsors:

Direction Générale de l'Offre de Soins

Laboratoires Thea

Conditions:

Ocular Inflammation

Ocular Prostheses

Eligibility:

All Genders

18-85 years

Phase:

PHASE3

Brief 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.

Detailed Description

There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are prop...

Eligibility 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.

Key Trial Info

Start Date :

May 12 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 20 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05668455

Start Date

May 12 2023

End Date

July 20 2026

Last Update

August 15 2025

Active Locations (1)

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Centre Hospitalier Universitaire de Rennes _ Pontchaillou

Rennes, France, 35000

Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses) | DecenTrialz