CTRI/2019/03/018319尚未招募4 期
Phase IV Controlled Clinical Study to Compare the Efficacy and Safety of CYCLOSPORINE (0.05%) Ophthalmic Emulsion against RESTASIS® in Subjects with Moderate to Severe Keratoconjunctivitis Sicca.
ew India Bio Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Male or female, between 18 and 65 years of age (both age inclusive).
- •2.Subjects presenting with documented signs and symptoms of moderate to severe Keratoconjunctivitis sicca (KCS) by diagnostic criteria as per investigators discretion.
- •3.History of KCS for a period of at least 6 months
- •4.Lack of clinically adequate improvement despite conventional management, which may have included artificial tear eye drops, topical parasympathomimetic agentâ??s topical steroids in the affected eye(s).
- •5. Schirmer Tear Test (ST) score (without anesthesia) <= 10 mm/5 min in at least one eye.
- •6. Positive corneal staining, defined as a corneal fluorescein staining (CFS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 5 areas each with a 0-3 scoring scale,where 0 equals to normal,and 3 equals to severe with a maximum total score of 15.
- •7.Positive conjunctival staining, defined as a conjunctival lissamine green staining (CLGS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 3 areas each with a 0-3 scoring scale, where 0 equals to normal and 3 equals to severe with a maximum total score of 18.
- •8. At least one of the following ocular symptoms scored at >=2, where a. 0 equals none and 4 equals to very severe/interferes with normal activities- photophobia, blurred vision, foreign body sensation, soreness or pain, itching, burning, dryness.
- •9.Ocular Surface Disease Index (OSDI) >=20;)
- •10.Best corrected visual acuity (BCVA) of 0.7 log MAR or better in each eye as assessed using an ETDRS chart
- •11.Normal lid position and closure.
排除标准
- •1.Present or history (in the preceding 6 months) of any systemic or ocular condition(s) that could possibly interfere with the interpretation of the study results;
- •2.Any disease of the eye leading to diffuse loss of conjunctiva;
- •3.Active anterior blepharitis;
- •4.A history or current evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
- •5.Current infections of the anterior segment or uveitis;
- •6.Uncontrolled systemic disease or the presence of any significant illness that can, in the judgment of the Investigator, interfere with interpretation of the study results;
- •7.Recent use (within 1 month) or anticipated use of temporary punctual plugs during the study;
- •8.Permanent occlusion of lacrimal puncta within 3 months of the study;
- •9.Subjects unwilling to discontinue contact lens wear at least one week prior to screening/ baseline visit and during the study duration;
- •10. Use of RESTASIS® (cyclosporine ophthalmic emulsion, 0.05%) or any other topical and/or systemic cyclosporine within 90 days before the study.
- •11.Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05%.
- •12. Diagnosis of Sjogrenâ??s disease Ë? 5 years prior to the Screening Visit.
- •13.Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
- •14.Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
- •15. Corneal transplant.
- •16. Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved;
- •17.Lasik surgery done within 6 months prior to screening visit.
- •18.Cataract surgery within 3 months prior to the screening visit.
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