Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

Alcon

Status and phase

Completed

Phase 4

Conditions

Dry Eye

Treatments

Other: Optive

Other: Systane

Study type

Interventional

Funder types

Industry

Identifiers

SMA-07-15

Details and patient eligibility

About

Comparison of two Dry Eye products

Enrollment

279 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).