Health Condition 1: null- Patients with Moderate to severe Dry Eye
Conditions
Interventions
Intervention1: Systane (Polyethylene glycol 400 0.4% &
Propylene glycol 0.3%): 1-2 drops in each eye, four times daily (QID)for 2 weeks
Control Intervention1: NIL: NIL
Sponsors
Alcon Laboratories India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 18 years of age or older, of both sexes, and any race, Willing and able to make all required visits and follow study instructions. A score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question. A sodium fluorescein corneal staining sum of >= 3 in either eye. A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
Exclusion criteria
Exclusion criteria: A history or evidence of ocular or intraocular surgery in either eye within the past six months. Lasik patients can be included if Lasik surgery was greater than 6 months prior to the initiation of the study. A history of intolerance or hypersensitivity to any component of the study medications. A history or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye. Use any other topical ocular medication during the study period. Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit 1. Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article. Unwilling to discontinue contact lens wear at least one week prior to Visit 1 and during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sum of the staining scores for the five corneal regions of each eye will be recorded at every visit. Tear break-up time will be assessed. Changes from baseline (Visit 1) in total staining scores and TBUT, will be computed at each visit Timepoint: Baseline to Visit 2 (Week 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety variables such as adverse events, best corrected visual acuity (logMAR), and ocular signs (eyelids, iris/anterior segment/lens). These variables will be collected at all visits.Timepoint: Baseline to Visit 2 (Week 2) | — |
Countries
India
Contacts
Public ContactMangesh Chaudhary
Alcon employee
Outcome results
None listed