Health Condition 1: H048- Other disorders of lacrimal system
Conditions
Interventions
Intervention1: systane complete drops (Propylene Glycol (0.6% w/v)): dosage and frequency : Propylene Glycol (0.6% w/v)
frequency - twice a day for 30 days
route of administration- topical eye drops
Sponsors
Alcon Research, Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects = 18years of age both gender 2. Subjects with known case of dry eye disease 3. Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better 4. Ocular Surface Disease Index (OSDI) : 13 - 33 5. Tear film break-up time (TBUT) = 10 seconds 6. Schirmer tear test (without anesthesia) = 10mm / 5min 7. MGD Score > 20 8. Normal lid position and closure 9. Willingness to sign written informed consent document
Exclusion criteria
Exclusion criteria: 1. Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This includes active ocular infection, ocular inflammation, ocular trauma, blepharitis, or, any other condition as deemed by the Investigator. 2. Unwilling to refrain from contact lens use for the entire duration of this study. 3. History of any other ocular surgical procedure within 3 months. 4. Subject with known allergy or hypersensitivity to the components of the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The mean change in the Ocular surface disease index score (OSDI). 2. The mean change in the MGD scores. Timepoint: 1.baseline and Day 30. 2.baseline and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean change in the Non-invasive tear film break-up time (NIBUT)Timepoint: baseline & Day 30. | — |
Countries
India
Contacts
Public ContactDr Namrata Sharma
All India Institute of Medical Sciences
Outcome results
None listed