Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

NCT ID: NCT00724412

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-02-28

Brief Summary

Comparison of two Dry Eye products

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Systane

Systane

Group Type: ACTIVE_COMPARATOR

Systane

Intervention Type: OTHER

Dry Eye relief eye drops

Optive

Optive

Group Type: ACTIVE_COMPARATOR

Optive

Intervention Type: OTHER

Dry Eye relief eye drops

Interventions

Systane

Dry Eye relief eye drops

Intervention Type: OTHER

Optive

Dry Eye relief eye drops

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SMA-07-15

Identifier Type: -

Identifier Source: org_study_id