Health Condition 1: H189- Unspecified disorder of cornea
Conditions
Interventions
Intervention1: Lubimoist Eye Drops (Sodium Hyaluronate BP 0.1%): Lubimoist eye drops containing Sodium Hyaluronate BP 0.1%, administered via topical ophthalmic instillation as one drop in the affect
Sponsors
Dr Sneha Dikshit
Eligibility
Inclusion criteria
Inclusion criteria: Trial participants aged 18 to 65 years (both inclusive), either male or female, who are willing to provide a written informed consent prior to study. Trial participants with a confirmed diagnosis of uncomplicated cataract and are planned to undergo cataract surgery as assessed by the site investigator. Trial participants with the ability and willingness to comply with study visits and treatment requirements. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication. Male trial participants must agree to use accepted methods of birth control with their partners.
Exclusion criteria
Exclusion criteria: Trial participants with moderate to severe dry eye disease prior to surgery. Trial participants with OSDI score greater than 22 at screening. Trial participants with tear break-up time (TBUT) less than 7 seconds at screening. Trial participants with Schirmer s test value less than 7.0 mm in 5 minutes at screening. Trial participants with concurrent ocular diseases that may affect study outcomes. Trial participants with anatomic or functional eyelid abnormalities including lagophthalmos or floppy eyelid syndrome. Trial participants who have used topical or systemic medications within 2 weeks prior to screening that may impact dry eye symptoms. Trial participants with complicated cataract surgery. Trial participants with known hypersensitivity to the study drug or its components. Trial participants who are pregnant or lactating. Trial participants with severe uncontrolled comorbidities. Trial participants with uncontrolled type 2 diabetes mellitus. Trial participants with uncontrolled cardiovascular diseases. Any other medical condition or medication that, in the opinion of the investigator, may interfere with study outcomes or participant safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of trial participants achieving improvement in quality of life and post-cataract ocular symptoms as assessed by National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), Ocular Surface Disease Index (OSDI) score, Tear Break-Up Time (TBUT), Schirmer s test, and Investigator Global Assessment (IGA).Timepoint: Baseline (Day 0), Day 01, Day 07, and End of Study (Day 35). | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring and reporting of ocular, non-ocular and treatment-emergent adverse events (AEs and TEAEs) in trial participants receiving Lubimoist eye drops in addition to standard of care.Timepoint: From Day 0 to End of Study (Day 35) | — |
Countries
India
Contacts
Public ContactDr Sneha Dikshit
Tirupati Eye Centre
Outcome results
None listed