Evaluation of Ocular Comfort With ISTA Tears vs Systane

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: ISTA Tears; Drug: Systane

• Registration Number: NCT01650584
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Disposition First Submitted: 2019-10-28
• Disposition First Submitted QC: 2019-10-28
• Disposition First Posted: 2019-11-06
• Results First Submitted: 2020-08-24
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Results First Posted: 2020-10-06
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• OSDI >12

Exclusion Criteria

• Presence of any active ocular disease other than dry eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ISTA Tears	ISTA Tears	Sterile ophthalmic solution
Systane	Systane	Sterile ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Preference for One of the Treatments	30 days	There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither.

Trial Locations

Locations (1)

ISTA Pharmaceuticals, Inc.; 🇺🇸 Irvine, California, United States