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

This study is currently recruiting participants.

Verified by Bp Consulting, Inc, September 2008

Sponsored by:	Bp Consulting, Inc
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00570843

Purpose

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.

Condition	Intervention	Phase
Comfort, Vision and Wear Time	Drug: New PEG based artificial tear Drug: Optive	Phase IV

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:

Comfort [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

vision and wear time [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Active Comparator	Drug: New PEG based artificial tear 1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
2.: Placebo Comparator	Drug: Optive 1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570843

Contacts

Contact: Michelle Chabot

714-246-9581

michelle_bpconsulting@yahoo.com

Locations

United States, New York
The New York Presbyterian Hospital-Weill Cornell Medical College	Recruiting
New York, New York, United States, 10021
Contact: Chris Starr, MD 212-746-2020 drstarr@gmail.com

Sponsors and Collaborators

Bp Consulting, Inc

Investigators

Principal Investigator:

Chris Starr, MD

The New York Presbyterian Hospital Weill Cornell Medical College

More Information

Responsible Party:	Weill Cornell Medical College- The New York Presbyterian Hospital ( Christopher Starr, MD )
Study ID Numbers:	0710009485
Study First Received:	December 7, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00570843
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on January 13, 2009