A Clinical Study to evaluate the efficacy, safety and tolerability of Lifitegrast 5% eye drops in patients with dry eye disease
- Conditions
- Health Condition 1: H041- Other disorders of lacrimal gland
- Registration Number
- CTRI/2021/10/037204
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 370
•Subjects >=18 years to 65 years of age both gender
•Subjects with known case of dry eye disease
•Subject on artificial tears for the past 30 days for DED
•Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better
•Normal lid position and closure.
•In case of women, postmenopausal ( >12 months without menstrual bleeding),
•Surgically sterilized, or on use of effective birth control measures
•Willingness to sign written informed consent document
•Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
•Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This include, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy or, any other condition as deemed by the Investigator.
•Any significant illness that could interfere with study parameters
•History of any other ocular surgical procedure within 12 months
•Subject with known allergy or hypersensitivity to the components of the formulation
•Participation in another clinical trial within past 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean change in Eye dryness scoreTimepoint: baseline, Week-2, Week-6 and Week-12
- Secondary Outcome Measures
Name Time Method The mean change in the Schirmer Tear Test (without anesthesia) <br/ ><br> <br/ ><br>The mean change in Subject rated global improvement scaleTimepoint: from baseline to Week-2, Week-6 and Week-12