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

Study Overview
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Brief Summary
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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
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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 proposed without scientific basis. A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled. We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses. 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.

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

Conditions
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Ocular Prostheses, Ocular Inflammation

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Dexamethasone
* Other: Povidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYDROCORTISONE<br>Topical corticosteroid : hydrocortisone | Drug: Hydrocortisone<br>* 1 drops 4 times a day<br>|
| Experimental: DEXAMETHASONE<br>Topical corticosteroid : dexamethasone | Drug: Dexamethasone<br>* 1 drops 4 times a day<br>|
| Placebo Comparator: POVIDONE<br>Topical : tear substitute | Other: Povidone<br>* 1 drops 4 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bulbar conjunctival inflammation score | Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe) | At inclusion visit (basal) | 
| Bulbar conjunctival inflammation score | Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe) | After first treatment period of 14 days | 
| Bulbar conjunctival inflammation score | Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe) | At 2 months (After second treatment period of 14 days) | 
| Bulbar conjunctival inflammation score | Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe) | At 3.5 months (After third treatment period of 14 days) | 
| Tarsal conjunctival inflammation score according | Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter) | At inclusion visit (basal) | 
| Tarsal conjunctival inflammation score according | Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter) | After first treatment period of 14 days | 
| Tarsal conjunctival inflammation score according | Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter) | At 2 months (After second treatment period of 14 days) | 
| Tarsal conjunctival inflammation score according | Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter) | At 3.5 months (After third treatment period of 14 days) | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | Before first treatment period of 14 days | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | After first treatment period of 14 days | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | At 1.5 month (Before second treatment period of 14 days | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | At 2 months (After second treatment period of 14 days | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | At 3 months (Before third treatment period of 14 days) | 
| Secretion frequency | Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.) | At 3.5 months (After third treatment period of 14 days) | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | Before first treatment period of 14 days | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | After first treatment period of 14 days | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | At 1.5 month (Before second treatment period of 14 days) | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | At 2 months (After second treatment period of 14 days | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | At 3 months (Before third treatment period of 14 days) | 
| Colour of secretions | Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.) | At 3.5 months (After third treatment period of 14 days) | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | Before first treatment period of 14 days | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | After first treatment period of 14 days | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | At 1.5 month (Before second treatment period of 14 days) | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | At 2 months (After second treatment period of 14 days | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | At 3 months (Before third treatment period of 14 days | 
| Amount of secretions | Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.) | At 3.5 months (After third treatment period of 14 days) | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | Before first treatment period of 14 days | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | After first treatment period of 14 days | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | At 1.5 month (Before second treatment period of 14 days) | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | At 2 months (After second treatment period of 14 days | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | At 3 months (Before third treatment period of 14 days) | 
| Thickness/Viscosity of secretions | Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.) | At 3.5 months (After third treatment period of 14 days) | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | Before first treatment period of 14 days | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | After first treatment period of 14 days | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | At 1.5 month (Before second treatment period of 14 days) | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | At 2 months (After second treatment period of 14 days | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | At 3 months (Before third treatment period of 14 days) | 
| OSDI quality of life score adapted to prosthesis wearers | OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.) | At 3.5 months (After third treatment period of 14 days) |