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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
1 drops 4 times a day
1 drops 4 times a day
1 drops 4 times a day
Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Rennes, France
RECRUITINGSecretion 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 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)
Time frame: At 3.5 months (After third 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: At 3.5 months (After third treatment period of 14 days)