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

NCT05668455 | Recruiting Phase 3

• 1 other identifier: 35RC21_8901_CRYSTAL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Inflammation; Ocular Prostheses

Outcome Measures

Primary Outcomes (6)

• Secretion Self-Rating Analog Scale score.

  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)

  Before first treatment period of 14 days

• Secretion Self-Rating Analog Scale score.

  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)

  After first treatment period of 14 days

• Secretion Self-Rating Analog Scale score.

  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)

  At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)

• Secretion Self-Rating Analog Scale score.

  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)

  At 2 months (After second treatment period of 14 days)

• Secretion Self-Rating Analog Scale score.

  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)

  At 3 months (1 Month Wash-out after second treatment, and before third treatment)

• Secretion Self-Rating Analog Scale score.

  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)

  At 3.5 months (After third treatment period of 14 days)

Secondary Outcomes (38)

• Bulbar conjunctival inflammation score

  At inclusion visit (basal)

• Bulbar conjunctival inflammation score

  After first treatment period of 14 days

• Bulbar conjunctival inflammation score

  At 2 months (After second treatment period of 14 days)

• Bulbar conjunctival inflammation score

  At 3.5 months (After third treatment period of 14 days)

• Tarsal conjunctival inflammation score according

  At inclusion visit (basal)

Study Arms (3)

HYDROCORTISONE

EXPERIMENTAL

Topical corticosteroid : hydrocortisone

Drug: Hydrocortisone

DEXAMETHASONE

EXPERIMENTAL

Topical corticosteroid : dexamethasone

Drug: Dexamethasone

POVIDONE

PLACEBO COMPARATOR

Topical : tear substitute

Other: Povidone

Interventions

Hydrocortisone DRUG

1 drops 4 times a day

HYDROCORTISONE

Dexamethasone DRUG

1 drops 4 times a day

DEXAMETHASONE

Povidone OTHER

1 drops 4 times a day

POVIDONE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agnes: lead
• Direction Générale de l'Offre de Soins: collaborator
• Laboratoires Thea: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Rennes _ Pontchaillou

Rennes, 35000, France

RECRUITING

MeSH Terms

Interventions

Hydrocortisone; Dexamethasone; Povidone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienetriols; Pregnadienes; Steroids, Fluorinated; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: re-labelling for clinical trials
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical trials Project manager

Model Details: Prospective, single-centre, controlled, randomised, single-blind, cross-over clinical study with 2 treatments and an artificial tear. (First treatment (14 days) and Wash out (1month) / Second treatment treatment (14 days) and Wash out (1month) /Third treatment (14 days) and Wash out (1month)

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: December 29, 2022
• Study Start: May 12, 2023
• Primary Completion: December 25, 2025
• Study Completion (Estimated): July 20, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

FR (1)