Effectiveness of systemic immunosuppressants for Dry-eyes in Sjogren disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in symptoms (OSDI) and signs (Ocular surface staining scores) at 6 months as compared with baseline. A minimum of 10% reduction will be taken as improvement.
研究概览
简要总结
This will be a prospective, observational, non-randomized study to determine the effectiveness of systemic immunosuppressants for dry eyes in Sjogren’s disease. The study will commence only after receiving IEC approval.
Rationale for the present study:
Although topical immunosuppressants are a standard of care for dry eyes in Sjogren’s, current literature is unclear about the benefit of systemic immunosuppression. Knowledge about effective immunotherapy for dry eyes, as well as predicting which patients will respond, may dramatically change the management of this challenging condition.
Study Procedure:
All diagnosed cases of Sjogren’s syndrome, according to the diagnostic criteria and started on oral medications by a rheumatologist and topical medications by an ophthalmologist, will undergo:
OSDI questionnaire, Schirmer I test (without anesthesia), Ocular Surface Analyzer (IDRA), Fluorescein Breakup Time (FBUT), Ocular Surface Staining Score (Fluorescein for cornea and Lissamine green staining for conjunctiva), direct assessment of tear secretion (DATS), labial mucosal staining, and diffuse slit lamp photography.
All parameters will be quantitatively measured and compared to baseline at 3-month, 6-month, 9-month, and 1-year intervals.
Pharmacological Agents:
-
Systemic immunomodulators as per the requirements for systemic disease. (This will be as per the treating rheumatologist, and no changes will be made for the sake of this study.)
-
Topical preservative-free lubricants plus topical Cyclosporine 0.09%, as prescribed by the treating ophthalmologist.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Sjogrens syndrome based on the American European Consensus Group 2002 revised criteria which requires the presence of at least 4 of 6 criteria or 3 of 4 objective criteria. The 6 criteria include.
- •subjective and objective ocular dryness.
- •subjective and objective evidence of salivary gland involvement (as determined by sialometry, sialography, or salivary gland scintigraphy) -presence of SSA/Ro, SSB/La, or both -positive minor salivary gland biopsy. A mandatory criterion for the diagnosis of primary SS was either positive serology (SSA or SSB) or positive minor salivary gland biopsy result.
排除标准
- •Pregnant and nursing mothers.
- •Ocular infections, and ocular or refractive surgery in the last three months.
- •Trauma to the globe, contact lens users.
- •Chronic users of any systemic or topical drugs causing dry eyes, such as antihistamines, anticholinergics, beta-blockers, diuretics, antidepressants, antipsychotics, and hormone replacement therapy, birth control pills or intrauterine devices (IUD).
- •Women with surgical menopause, the paediatric population, and psychiatric patients.
结局指标
主要结局
Improvement in symptoms (OSDI) and signs (Ocular surface staining scores) at 6 months as compared with baseline. A minimum of 10% reduction will be taken as improvement.
时间窗: 6 months
次要结局
- 1. Improvement in OSDI and in Ocular surface staining scores at 3 and 12 months(2. Improvement in Schirmer and Flourescein break-up score at 3, 6 and 12 months)
研究者
Dr Smruti Rekha Priyadarshini
L V Prasad Eye Institute