Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
Intervention1: Polyethylene glycol 400, Propylene glycol lubricant eye gel E.P: Dry eye disease treatment,1 drop (30microlitre) 4times/day for 1 month via ocular cul-de-sac
Control Intervention1: Not
Sponsors
Alcon Laboratories Ind Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: (Healthy volunteers) Inclusion criteria 1. Normal subjects with DEQ=10 Sec 2. Male or female adults aged >18 years and 3. BCVA of >= 20/40 in each eye as measured (Dry eye subjects) Inclusion criteria: 1. Male or female adults aged >18 years and 2. DEQ-5 Score >= 6 3. TBUT 4. BCVA of >= 20/40 in each eye as
Exclusion criteria
Exclusion criteria: Healthy volunteers Exclusion criteria: 1. Any history of Steven Johnson syndrome, Trachoma or Ocular Herpes simplex or Herpes zoster 2. History of scars in the cornea due to trauma, infection 3. History of infection or inflammation during the last 30 days 4. Corneal conditions other than dry eyes â?? dystrophy, epitheliopathies, pterygium, keratoconus 5. Post refractive surgeries 6. Post corneal transplant ( PK/LK/ DSEK/ DMEK etc) 7. Presence of punctal plugs or thermal cautery to the puncta 8. Lagophthalmos or Ptosis 9. Patients on Antiglaucoma medications. 10. Patient who are using systemic medications known to cause dry eyes 11. Patient who are on contact lens use DRY EYE SUBJECTS Exclusion criteria: 1. Any history of Steven Johnson syndrome, Trachoma or Ocular Herpes simplex or Herpes zoster 2. History of scars in the cornea due to trauma, infection 3. History of infection or inflammation during the last 30 days 4. Corneal conditions other than dry eyes â?? dystrophy, epitheliopathies, pterygium, keratoconus 5. Post refractive surgeries 6. Post corneal transplant ( PK/LK/ DSEK/ DMEK etc) 7. Presence of punctal plugs or thermal cautery to the puncta 8. Lagophthalmos or Ptosis 9. Patients on Antiglaucoma medications. 10. Patient who are using systemic medications known to cause dry eyes 11. Patient who are on contact lens use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: ocular residence time of systane gel Cohort 2: corneal staining score Timepoint: Cohort 1: less than 02 Hours Cohort 2: 01 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1:Tear film height, TBUT, OPI, Blur Profile Cohort 2: OPI, TBUT, DEQ-5, Tear film height, Ocular residence time, Blur profile Timepoint: 1 month | — |
Countries
India
Contacts
Public ContactDr Rachapalle Reddi Sudhir
Ophthalmologist, Sankara Nethralaya
Outcome results
None listed