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

Официальное название

Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Hydrocortisone
  1 drops 4 times a day
• Препарат Dexamethasone
  1 drops 4 times a day
• Другое Povidone
  1 drops 4 times a day

Первичные конечные точки

• Secretion Self-Rating Analog Scale score. [Срок оценки: Before first treatment period of 14 days]
• Secretion Self-Rating Analog Scale score. [Срок оценки: After first treatment period of 14 days]
• Secretion Self-Rating Analog Scale score. [Срок оценки: At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)]
• Secretion Self-Rating Analog Scale score. [Срок оценки: At 2 months (After second treatment period of 14 days)]
• Secretion Self-Rating Analog Scale score. [Срок оценки: At 3 months (1 Month Wash-out after second treatment, and before third treatment)]
• Secretion Self-Rating Analog Scale score. [Срок оценки: At 3.5 months (After third treatment period of 14 days)]

Вторичные конечные точки (12)

• Bulbar conjunctival inflammation score [Срок оценки: At inclusion visit (basal)]
• Bulbar conjunctival inflammation score [Срок оценки: After first treatment period of 14 days]
• Bulbar conjunctival inflammation score [Срок оценки: At 2 months (After second treatment period of 14 days)]
• Bulbar conjunctival inflammation score [Срок оценки: At 3.5 months (After third treatment period of 14 days)]
• Tarsal conjunctival inflammation score according [Срок оценки: At inclusion visit (basal)]
• Tarsal conjunctival inflammation score according [Срок оценки: After first treatment period of 14 days]
• Tarsal conjunctival inflammation score according [Срок оценки: At 2 months (After second treatment period of 14 days)]
• Tarsal conjunctival inflammation score according [Срок оценки: At 3.5 months (After third treatment period of 14 days)]
• Secretion frequency [Срок оценки: Before first treatment period of 14 days]
• Secretion frequency [Срок оценки: After first treatment period of 14 days]
• Secretion frequency [Срок оценки: At 1.5 month (Before second treatment period of 14 days]
• Secretion frequency [Срок оценки: At 2 months (After second treatment period of 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Centre Hospitalier Universitaire de Rennes _ Pontchaillou — Rennes

Идентификаторы

NCT: NCT05668455 · 35RC21_8901_CRYSTAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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