Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
| Laboratoires Thea | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYDROCORTISONE | Experimental | Topical corticosteroid : hydrocortisone |
|
| DEXAMETHASONE | Experimental | Topical corticosteroid : dexamethasone |
|
| POVIDONE | Placebo Comparator | Topical : tear substitute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | 1 drops 4 times a day |
| |
| Dexamethasone |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Rennes _ Pontchaillou | Recruiting | Rennes | 35000 | France |
Not provided
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D003907 | Dexamethasone |
| D011205 | Povidone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
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)
Not provided
Not provided
re-labelling for clinical trials
| Drug |
1 drops 4 times a day |
|
| Povidone | Other | 1 drops 4 times a day |
|
| 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) |
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) |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D013259 | Steroids, Fluorinated |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |