CTRI/2010/091/000095已完成4 期
An open label, multicentre postmarketing surveillance to evaluate the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Mean change in Schirmers tear test score
研究概览
简要总结
This is a Phase- IV open label post marketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease. This study was conducted at four centres through out the India. This study consists of 4 weeks of treatment period. In this study Mean change in Schirmer's test score at week four from the baseline visit was determined as a primary endpoint. Mean change in Ocular Surface Disease Index Score, mean change in Ocular Discomfort, global evaluation of overall effect of study medication and use of artificial tears were determined as secondary endpoints. Incidence and nature of drug related adverse events, clinically significant changes in the ocular examination were assessed as a safety endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects willing to give written informed consent.
- •2.Subjects of either sex of 18 years and above.
- •3.Ocular Surface Disease Index Score greater than or equal to 0.25, unless subject has Sjogren syndrome or thyroid autoimmune disease.
- •4.Schirmer?s test with anesthesia of less than 5 mm / 5 min.
- •5.Best corrected visual acuity greater than 6/
- •6.In the opinion of the investigator, able to comply with the requirements of the protocol.
排除标准
- •1.Subjects with hypersensitivity to study drug or any exipients of its formulation.
- •2.Presence or history of any systemic or ocular disorder or condition including ocular surgery, trauma, or ocular disease that could interfere with interpretation of study results.
- •3.Current or recent use of topical ophthalmic or systemic medications that could affect dry eye condition.
- •4.Required contact lenses wear during study.
- •5.Current infections of the anterior segment or uveitis.
- •6.Any disease of the eye leading to diffuse loss of conjunctiva including ocular pemphigoid, chemical burns, steven Johnson syndrome and hypervitaminosis A.
- •7.Any active ocular diseases excluding glaucoma other than blepharitis.
- •8.Within one month or anticipated use of temporary punctual plugs during study or permanent occlusion of lacrimal puncta within 3 months.
- •9.Participated in an investigational study 30 days prior to screening visit.10.Females who are pregnant, lactating or planning to become pregnant.11.End stage Lacrimal gland disease (scheimer's reading with nasal stimulation of < 3 mm/5min) or if the dry eye disease is as a result of destruction of conjunctival goblet cells or scarring.
- •12.Judged by Investigator to be inappropriate as subjects.
结局指标
主要结局
Mean change in Schirmers tear test score
时间窗: At week 4 from baseline
次要结局
- Mean change in Ocular Surface Disease Index Score(At week 2 and week 4 from baseline)
- Mean change in Ocular discomfort(At week 2 and week 4 from baseline)
- Global evaluation of overall effect of study medication(At week 4 from baseline)
- Use of artificial tears(At week 4 from baseline)
- Incidence and nature of adverse events(During the study period)
- Incidence of drug related adverse events(During the study period)
- Clinically significant changes in the ocular examination(During the study period)
研究者
研究点 (4)
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