Evaluation of Ocular Comfort With ISTA Tears vs Systane

Dry Eye Disease Clinical Trial

Official title:

Evaluation of Ocular Comfort With ISTA Tears vs Systane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650584
• Other study ID #: S00231
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• OSDI >12

Exclusion Criteria:

• Presence of any active ocular disease other than dry eye

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• ISTA Tears
sterile ophthalmic solution
• Systane
Sterile ophthalmic solution

Locations

Country	Name	City	State
United States	ISTA Pharmaceuticals, Inc.	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Preference for One of the Treatments	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.	30 days