Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

NCT00724412 | Completed Phase 4

• 1 other identifier: SMA-07-15
• Study Type: interventional
• Target: 279
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of two Dry Eye products

Conditions

Dry Eye

Keywords

Dry Eye; Corneal Staining

Outcome Measures

Primary Outcomes (1)

• Tear Break-up time

  42 days

Study Arms (2)

Systane

ACTIVE COMPARATOR

Systane

Other: Systane

Optive

ACTIVE COMPARATOR

Optive

Other: Optive

Interventions

Systane OTHER

Dry Eye relief eye drops

Systane

Optive OTHER

Dry Eye relief eye drops

Optive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 2, 2012

Record last verified: 2012-01