Safety and efficacy of Topical Cyclosporine on Moderate to Severe Dry Eye: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 1. To assess the safety of 0.05% Cyclosporine A versus 0.1% among patients with moderate to sever dry eye.
研究概览
简要总结
Dry eye disease (DED) is a multifactorial condition of the ocular surface and tear film characterized by the loss of tear film homeostasis. It affects 5 percent to 50 percent of the adult population globally, with a prevalence of 29.5 percent to 39.62 percent reported in India . Moderate to severe DED can impair daily activities, social functioning, and quality of life . If left untreated, it may lead to chronic corneal epithelial damage, ulceration, and even vision loss or functional blindness in rare cases. Artificial tears remain the mainstay of conventional DED therapy, offering only temporary symptom relief without addressing the underlying inflammation. Cyclosporine A (CsA), an immunomodulatory agent, reduces ocular surface inflammation and promotes tear production. The FDA has approved 0.05 percent topical CsA for moderate to severe DED. RCTs have demonstrated its efficacy over vehicle in improving Schirmer scores and reducing corneal staining. It is considered safe and effective for patients not responding to artificial tears alone. Recent meta-analyses suggest that 0.1 percent CsA is also safe and more effective than vehicle in reducing corneal and conjunctival staining and OSDI scores.The ESSENCE-2 trial confirmed the safety and efficacy of 0.1 percent CsA compared to vehicle but did not evaluate it against artificial tears, limiting its generalizability to real-world clinical practice. A direct comparison between 0.05 percent and 0.1 percent CsA as add-on therapy to artificial tears is needed to establish the superior dose for improving symptoms and clinical outcomes in moderate to severe DED. Our study aims to compare the efficacy and safety of topical 0.05 percent versus 0.1 percent cyclosporine A, both as adjuncts to artificial tears, in patients with moderate to severe dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Total corneal fluorescein staining (CFS) score greater than or equal to 10
- •Dryness symptom score greater than or equal to 50
- •Total conjunctival staining score greater than or equal to 2
- •Schirmer I test score (without anaesthesia): between 1 mm and 10 mm at 5 minutes
- •Willing and able to comply with the study protocol and scheduled visits
- •Willing provide written informed consent.
排除标准
- •Active ocular infection or inflammation not related to dry eye
- •Ocular surgery or trauma within the past 3 months
- •Use of topical ocular anti-inflammatory medications (including steroids) within 30 days prior to screening
- •Known allergy or hypersensitivity to cyclosporine or any study medication components
- •Presence of systemic autoimmune diseases affecting the eyes
- •Pregnant or breastfeeding women
- •Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- •Ocular/periocular malignancy
- •History of herpetic keratitis
- •Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study 11.
结局指标
主要结局
1. To assess the safety of 0.05% Cyclosporine A versus 0.1% among patients with moderate to sever dry eye.
时间窗: Baseline , 1.5 month, 3 month, 6 month
2. To evaluate the change in Schirmer’s test values in both the groups.
时间窗: Baseline , 1.5 month, 3 month, 6 month
次要结局
- • To assess the improvement in ocular symptoms (e.g., burning, dryness, foreign body sensation) after treatment with two different regimen of Cyclosporine A (0.05% vs. 0.1%) plus artificial tear.(• To assess changes in Tear Break-Up Time (TBUT) and corneal/conjunctival staining scores.)
研究者
Dr Phulen Sarma
AIIMS, Guwahati