Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

Phase 4

Completed

• Conditions: Comfort, Vision and Wear Time
• Interventions: Drug: New PEG based artificial tear; Drug: Optive

• Registration Number: NCT00570843
• Lead Sponsor: Bp Consulting, Inc

Brief Summary

The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Study Start: 2008-03
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-19
• Last Update Posted: 2010-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
• Able to wear contact lenses for approximately 10-12 hours/day
• Willingness to complete entire length of trial and comply with subjective questionnaire.

Exclusion Criteria

• Patients taking topical cyclosporine (Restasis)
• Patients currently using Optive for dryness relief.
• Patients wearing hard or rigid gas permeable lenses
• Patients with uncontrolled systemic disease which may confound the results of the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.	New PEG based artificial tear	-
2.	Optive	-

Primary Outcome Measures

Name	Time	Method
Comfort	1 month

Secondary Outcome Measures

Name	Time	Method
vision and wear time	1 month

Trial Locations

Locations (1)

The New York Presbyterian Hospital-Weill Cornell Medical College; 🇺🇸 New York, New York, United States