Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
NCT05668455

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

Led by Agnes · Updated on 2025-08-15

30

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

A

Agnes

Lead Sponsor

D

Direction Générale de l'Offre de Soins

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years or older
  • Wearing a permanent prosthesis for more than 6 months
  • Modified OSDI score 20 points or higher out of 40
  • Affiliated with a health insurance scheme
  • For women of childbearing age: using effective contraception during the study and for one week after the last dose
  • Provided free, informed, and written consent
Not Eligible

You will not qualify if you...

  • Treatment with eye drops (other than artificial tears or antiseptic) within the past month
  • Using CYP3A inhibitors including cobicistat-containing drugs
  • Known contraindications to study treatments
  • Dermal fat grafting or complicated ocular cavity
  • Gougerot-Sjögren syndrome
  • Allergic conjunctivitis
  • Damaged prosthesis
  • Unable to complete required tests due to comprehension or motor difficulties
  • Pregnant or breastfeeding
  • Currently in another RIPH1 study involving topical or systemic anti-inflammatory treatment
  • Under legal protection or deprived of liberty

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire de Rennes _ Pontchaillou

Rennes, France, 35000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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