Clinical trial NCT05668455: Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Official title: Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ocular Inflammation
Ocular Prostheses
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
name: Laboratoires Thea
First posted: 2022-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Secretion Self-Rating Analog Scale score.
timeFrame: Before first treatment period of 14 days
measure: Secretion Self-Rating Analog Scale score.
timeFrame: After first treatment period of 14 days
measure: Secretion Self-Rating Analog Scale score.
timeFrame: At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)
measure: Secretion Self-Rating Analog Scale score.
timeFrame: At 2 months (After second treatment period of 14 days)
measure: Secretion Self-Rating Analog Scale score.
timeFrame: At 3 months (1 Month Wash-out after second treatment, and before third treatment)
measure: Secretion Self-Rating Analog Scale score.
timeFrame: At 3.5 months (After third treatment period of 14 days)
Secondary outcomes:
measure: Bulbar conjunctival inflammation score
timeFrame: At inclusion visit (basal)
measure: Bulbar conjunctival inflammation score
timeFrame: After first treatment period of 14 days
measure: Bulbar conjunctival inflammation score
timeFrame: At 2 months (After second treatment period of 14 days)
measure: Bulbar conjunctival inflammation score
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: Tarsal conjunctival inflammation score according
timeFrame: At inclusion visit (basal)
measure: Tarsal conjunctival inflammation score according
timeFrame: After first treatment period of 14 days
measure: Tarsal conjunctival inflammation score according
timeFrame: At 2 months (After second treatment period of 14 days)
measure: Tarsal conjunctival inflammation score according
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: Secretion frequency
timeFrame: Before first treatment period of 14 days
measure: Secretion frequency
timeFrame: After first treatment period of 14 days
measure: Secretion frequency
timeFrame: At 1.5 month (Before second treatment period of 14 days
measure: Secretion frequency
timeFrame: At 2 months (After second treatment period of 14 days
measure: Secretion frequency
timeFrame: At 3 months (Before third treatment period of 14 days)
measure: Secretion frequency
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: Colour of secretions
timeFrame: Before first treatment period of 14 days
measure: Colour of secretions
timeFrame: After first treatment period of 14 days
measure: Colour of secretions
timeFrame: At 1.5 month (Before second treatment period of 14 days)
measure: Colour of secretions
timeFrame: At 2 months (After second treatment period of 14 days
measure: Colour of secretions
timeFrame: At 3 months (Before third treatment period of 14 days)
measure: Colour of secretions
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: Amount of secretions
timeFrame: Before first treatment period of 14 days
measure: Amount of secretions
timeFrame: After first treatment period of 14 days
measure: Amount of secretions
timeFrame: At 1.5 month (Before second treatment period of 14 days)
measure: Amount of secretions
timeFrame: At 2 months (After second treatment period of 14 days
measure: Amount of secretions
timeFrame: At 3 months (Before third treatment period of 14 days
measure: Amount of secretions
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: Thickness/Viscosity of secretions
timeFrame: Before first treatment period of 14 days
measure: Thickness/Viscosity of secretions
timeFrame: After first treatment period of 14 days
measure: Thickness/Viscosity of secretions
timeFrame: At 1.5 month (Before second treatment period of 14 days)
measure: Thickness/Viscosity of secretions
timeFrame: At 2 months (After second treatment period of 14 days
measure: Thickness/Viscosity of secretions
timeFrame: At 3 months (Before third treatment period of 14 days)
measure: Thickness/Viscosity of secretions
timeFrame: At 3.5 months (After third treatment period of 14 days)
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: Before first treatment period of 14 days
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: After first treatment period of 14 days
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: At 1.5 month (Before second treatment period of 14 days)
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: At 2 months (After second treatment period of 14 days
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: At 3 months (Before third treatment period of 14 days)
measure: OSDI quality of life score adapted to prosthesis wearers
timeFrame: At 3.5 months (After third treatment period of 14 days)
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Study officials:
References: