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

Agnes

Status and phase: Enrolling; Phase 3

Conditions: Ocular Prostheses; Ocular Inflammation

Treatments: Drug: Dexamethasone; Other: Povidone; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05668455

35RC21_8901_CRYSTAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

HYDROCORTISONE

Experimental group

Description:

Topical corticosteroid : hydrocortisone

Treatment:

Drug: Hydrocortisone

DEXAMETHASONE

Experimental group

Description:

Topical corticosteroid : dexamethasone

Treatment:

Drug: Dexamethasone

POVIDONE

Placebo Comparator group

Description:

Topical : tear substitute

Treatment:

Other: Povidone