Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Willing to participate in the study and must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study Male or female Age of above 18 years (completed years) at the time of signing the informed consent. Patients with an OSDI score between 13 and 22. Treatment na?ve patients No history of ocular surgery within the last 6 months. No systemic diseases affecting tear production. History of allergic reactions to any component of the study medication Concurrent use of other ocular medications that could interfere with study outcomes
Exclusion criteria
Exclusion criteria: History of allergic reactions to any component of the study medication Concurrent use of other ocular medications that could interfere with study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in OSDI score from baselineTimepoint: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in OSA test ( NIBUT, LLT, TMH, and MG loss) from baselineTimepoint: week 4 and 8;Improvemnt in Patient perception scoreTimepoint: week 8;Clinically significant changes in ocular examinationTimepoint: During study period;Incidence and nature of adverse eventsTimepoint: During study period | — |
Countries
India
Contacts
Sadguru Netra Chikitsalaya