A new drug as an adjunct therapy for patients of dry eye disease
Phase 1
- Conditions
- Health Condition 1: H048- Other disorders of lacrimal system
- Registration Number
- CTRI/2024/04/065924
- Lead Sponsor
- Dr RP Centre Of Ophthalmic Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients more than 18 years of age with moderate to severe dry eye disease
Tear film breakup time less than or equal to seven seconds
Schirmers test less than or equal to 10mm for 5 min
OSDI Score more than equal to 13
Exclusion Criteria
Patients not consenting to follow up
Presence of active systemic or ocular infection
Allergic to any topical eye drops
Use of contact lens within last two weeks
Pregnant or lactating
Associated ocular inflammatory conditions
Any cognitive or psychiatric deficit that precludes consent or ability to perform
Hace active drug or alcohol dependance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scores of ocular surface evaluation tests such as OSDI Score, TFOSE DEWS 2 Score, TBUT, NEI conjunctival and corneal staining score, Schirmers test, Conjunctival hyeremia score, Mucid strands score <br/ ><br>Changes in meibomian gland and tear imaging as LIPIVIEW for Lipid layer thickness, Tear meniscus height, Non invasive tear breakup time and mebomian gland lossTimepoint: At baseline, 2 weeks, 1 month, 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Visual acuity assessment <br/ ><br>Tolerability to eye drops <br/ ><br>Drug adherence using treatment grading scaleTimepoint: At baseline <br/ ><br>2weeks <br/ ><br>1 month <br/ ><br>3 months <br/ ><br>6 months