Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
ID05668455

Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjunctiva in Patients With Ocular Prostheses

Led by Agnes · Updated on 2025-08-15

30

Participants Needed

1

Research Sites

29 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

Researchers are studying the effects of two topical corticosteroid treatments, Hydrocortisone and Dexamethasone, in adults who wear ocular prostheses and experience significant discomfort from inflammatory secretions. This trial aims to determine the value of these anti-inflammatory treatments compared to a placebo in reducing symptoms and improving comfort for these patients. The study is a prospective, randomized, single-blind clinical trial designed to provide controlled evidence for treatment effectiveness. Participants will receive three different treatments in a cross-over design: Hydrocortisone eye drops, Dexamethasone eye drops, and a tear substitute (Povidone) used as a placebo. Each treatment period lasts 14 days, separated by one-month wash-out phases. The treatments are administered as one drop four times a day. This design allows each participant to receive all treatments in sequence, helping compare their effects individually. During the study, participants will be evaluated at multiple time points before, during, and after each treatment phase. Researchers will use self-rating scales to measure secretion symptoms and assess conjunctival inflammation through clinical scores. They will also monitor secretion frequency, color, amount, and viscosity, as well as quality of life using a specific questionnaire adapted for prosthesis wearers. The total study duration per participant is about 3.5 months, including treatment and wash-out periods, with regular visits for assessments and monitoring.

CONDITIONS

Brief 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 of 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 up to 1 week after 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 antiseptics) within the last 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
  • Unable to complete required tests due to comprehension or motor disabilities
  • Pregnant or breastfeeding women
  • Participation in another research protocol involving topical or systemic anti-inflammatory treatment that may bias this study
  • Persons under legal protection or deprived of liberty

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3.5 months including treatment and wash-out periods

Participants receive three successive 14-day treatment periods with topical eye drops: Hydrocortisone, Dexamethasone, and Povidone (placebo), in a randomized cross-over design with 1-month wash-out periods between treatments.

Multiple visits including baseline and assessments after each 14-day treatment period and wash-out

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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