Status:
COMPLETED
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Comparison of two Dry Eye products
Eligibility Criteria
Inclusion
- Inclusion:
- Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
- Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
- 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:
- 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 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
- 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).
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT00724412
Start Date
April 1 2008
End Date
February 1 2009
Last Update
February 2 2012
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