NCT00724412CompletedPhase 4
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 279
- Primary Endpoint
- Tear Break-up time
Study Overview
Brief Summary
Comparison of two Dry Eye products
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.
- •Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.
- •Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.
Exclusion Criteria
- •Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or 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 of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit
- •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
- •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 7 days prior to Visit 1 and during the study period.
- •Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
Arms & Interventions
Optive
Active Comparator
Optive
Intervention: Optive (Other)
Systane
Active Comparator
Systane
Intervention: Systane (Other)
Outcomes
Primary Outcomes
Tear Break-up time
Time Frame: 42 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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