Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Secretion Self-Rating Analog Scale score.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
re-labelling for clinical trials
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
DEXAMETHASONE
Topical corticosteroid : dexamethasone
干预措施: Dexamethasone (Drug)
HYDROCORTISONE
Topical corticosteroid : hydrocortisone
干预措施: Hydrocortisone (Drug)
POVIDONE
Topical : tear substitute
干预措施: Povidone (Other)
结局指标
主要结局
Secretion Self-Rating Analog Scale score.
时间窗: At 3.5 months (After third treatment period of 14 days)
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)
次要结局
- Bulbar conjunctival inflammation score(At 3.5 months (After third treatment period of 14 days))
- Colour of secretions(At 3.5 months (After third treatment period of 14 days))
- Tarsal conjunctival inflammation score according(At 3.5 months (After third treatment period of 14 days))
- Secretion frequency(At 3.5 months (After third treatment period of 14 days))
- Amount of secretions(At 3.5 months (After third treatment period of 14 days))
- Thickness/Viscosity of secretions(At 3.5 months (After third treatment period of 14 days))
- OSDI quality of life score adapted to prosthesis wearers(At 3.5 months (After third treatment period of 14 days))
研究者
Agnes
Clinical trials Project manager
Rennes University Hospital