Health Condition 1: null- Patients with moderate to severe dry eye
Conditions
Interventions
Intervention1: Systane: one drop 3 times daily in both eyes
Control Intervention1: Refresh Tears: one drop 3 times a day in both eyes
Sponsors
Alcon laboratoriesIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient must be 18 years of age or older of any sexes and any race, with 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 Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1. 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. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs). Participation in any investigational drug or device study within 30 days of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the physical effects of Systane and Refresh Tears in subjects with moderate to severe dry eyeTimepoint: This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3. | — |
Countries
India
Contacts
Public ContactDrSalman Anzer
Vasan Eye Care hospital
Outcome results
None listed