Dry Eye
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
Interventions
DRUGSystane, Optive, Restasis
Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed
Sponsors
Innovative Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* · Males or females \> 18 years old * Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients) * At least Grade 2 conjunctival staining * Likely to complete all study visits and able to provide informed consent
Exclusion criteria
* · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements) * Current use of topical cyclosporine * Known contraindications to any study medication or ingredients * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. * Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization) * Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable) * Ocular surgery within the past 3 months, * Active ocular allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | 1 yr 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Dry eye symptoms | 1yr 3 months |
Countries
United States
Outcome results
None listed