Back to resultsComparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses) (CRYSTAL)
Primary Purpose
Ocular Inflammation, Ocular Prostheses
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hydrocortisone
Dexamethasone
Povidone
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation
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.
Sites / Locations
- Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
HYDROCORTISONE
DEXAMETHASONE
POVIDONE
Arm Description
Topical corticosteroid : hydrocortisone
Topical corticosteroid : dexamethasone
Topical : tear substitute
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
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)
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)
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)
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)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
Full Information
NCT ID
NCT05668455
First Posted
October 3, 2022
Last Updated
August 8, 2023
Sponsor
Agnes
Collaborators
Direction Générale de l'Offre de Soins, Laboratoires Thea
1. Study Identification
Unique Protocol Identification Number
NCT05668455
Brief Title
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Acronym
CRYSTAL
Official Title
Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
May 25, 2025 (Anticipated)
Study Completion Date
July 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Agnes
Collaborators
Direction Générale de l'Offre de Soins, Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation, Ocular Prostheses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
re-labelling for clinical trials
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HYDROCORTISONE
Arm Type
Experimental
Arm Description
Topical corticosteroid : hydrocortisone
Arm Title
DEXAMETHASONE
Arm Type
Experimental
Arm Description
Topical corticosteroid : dexamethasone
Arm Title
POVIDONE
Arm Type
Placebo Comparator
Arm Description
Topical : tear substitute
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
1 drops 4 times a day
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
1 drops 4 times a day
Intervention Type
Other
Intervention Name(s)
Povidone
Intervention Description
1 drops 4 times a day
Primary Outcome Measure Information:
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
Before first treatment period of 14 days
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
After first treatment period of 14 days
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
At 2 months (After second treatment period of 14 days)
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
At 3 months (1 Month Wash-out after second treatment, and before third treatment)
Title
Secretion Self-Rating Analog Scale score.
Description
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)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Secondary Outcome Measure Information:
Title
Bulbar conjunctival inflammation score
Description
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time Frame
At inclusion visit (basal)
Title
Bulbar conjunctival inflammation score
Description
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time Frame
After first treatment period of 14 days
Title
Bulbar conjunctival inflammation score
Description
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time Frame
At 2 months (After second treatment period of 14 days)
Title
Bulbar conjunctival inflammation score
Description
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
Tarsal conjunctival inflammation score according
Description
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)
Time Frame
At inclusion visit (basal)
Title
Tarsal conjunctival inflammation score according
Description
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)
Time Frame
After first treatment period of 14 days
Title
Tarsal conjunctival inflammation score according
Description
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)
Time Frame
At 2 months (After second treatment period of 14 days)
Title
Tarsal conjunctival inflammation score according
Description
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)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
Secretion frequency
Description
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.)
Time Frame
Before first treatment period of 14 days
Title
Secretion frequency
Description
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.)
Time Frame
After first treatment period of 14 days
Title
Secretion frequency
Description
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.)
Time Frame
At 1.5 month (Before second treatment period of 14 days
Title
Secretion frequency
Description
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.)
Time Frame
At 2 months (After second treatment period of 14 days
Title
Secretion frequency
Description
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.)
Time Frame
At 3 months (Before third treatment period of 14 days)
Title
Secretion frequency
Description
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.)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
Before first treatment period of 14 days
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
After first treatment period of 14 days
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 1.5 month (Before second treatment period of 14 days)
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 2 months (After second treatment period of 14 days
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3 months (Before third treatment period of 14 days)
Title
Colour of secretions
Description
Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
Before first treatment period of 14 days
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
After first treatment period of 14 days
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 1.5 month (Before second treatment period of 14 days)
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 2 months (After second treatment period of 14 days
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3 months (Before third treatment period of 14 days
Title
Amount of secretions
Description
Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
Before first treatment period of 14 days
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
After first treatment period of 14 days
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
At 1.5 month (Before second treatment period of 14 days)
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
At 2 months (After second treatment period of 14 days
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3 months (Before third treatment period of 14 days)
Title
Thickness/Viscosity of secretions
Description
Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)
Time Frame
At 3.5 months (After third treatment period of 14 days)
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
Before first treatment period of 14 days
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
After first treatment period of 14 days
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
At 1.5 month (Before second treatment period of 14 days)
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
At 2 months (After second treatment period of 14 days
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
At 3 months (Before third treatment period of 14 days)
Title
OSDI quality of life score adapted to prosthesis wearers
Description
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.)
Time Frame
At 3.5 months (After third treatment period of 14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Rennes _ Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic MOURIAUX, MD
Email
frederic.mouriaux@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Yann MAUCOURANT
Email
yann.maucourant@chu-rennes.fr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
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