Health Condition 1: H04- Disorders of lacrimal system
Conditions
Interventions
Intervention1: Lifitegrast 5 percent eye drops: Given to moderate to severe dry eye patients one drop in each eye twice daily
Control Intervention1: Chloroquine 0.03 percent eye drops
: Given to mode
Sponsors
JPM Rotary Club of Cuttack Eye Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed dry eye based on OSDI score lesser than 13 and TBUT lesser than 10 sec Schirmer test lesser than 10 mm without anesthesia Willing to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: Presence of ocular surface diseases that might interfere with dry eye assessment example severe blepharitis active ocular infections, allergic conjunctivitis History of ocular surgery in the past 6 months Use of systemic medications affecting tear production or ocular surface Known hypersensitivity or contraindication to chloroquine, lifitegrast, or cyclosporine Pregnant or breastfeeding women Any systemic illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Breakup Time Improvement from baseline to 12 weeks Ocular Surface Disease Index Score Change from baseline to 12 weeksTimepoint: Tear Breakup Time Improvement from baseline to 12 weeks Ocular Surface Disease Index Score Change from baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Schirmer s Test (without anesthesia): Tear production Corneal and conjunctival staining (fluorescein and lissamine green): Ocular surface assessment Patient-reported symptom relief and quality of life: Using standardized dry eye questionnaireTimepoint: Schirmer s Test and staining: Baseline (Week 0) and Week 12 Patient-reported symptom relief and quality of life: Baseline (Week 0), Week 4, Week 8, and Week 12 | — |
Countries
India
Contacts
Public ContactSHWETA DHIMAN
JPM ROTARY EYE HOSPITAL AND RESEARCH INSTITUTE
Outcome results
None listed