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

February 19, 2010 updated by: Bp Consulting, Inc

Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • The New York Presbyterian Hospital-Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2.
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)
Active Comparator: 1.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comfort
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
vision and wear time
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bp Consulting, Inc

Investigators

  • Principal Investigator: Chris Starr, MD, The New York Presbyterian Hospital Weill Cornell Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 19, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0710009485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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