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

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00570843
First received: December 7, 2007
Last updated: February 19, 2010
Last verified: February 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
The New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Bp Consulting, Inc
Investigators
Principal Investigator: Chris Starr, MD The New York Presbyterian Hospital Weill Cornell Medical College
  More Information

No publications provided

Responsible Party: Christopher Starr, MD, Weill Cornell Medical College- The New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT00570843     History of Changes
Other Study ID Numbers: 0710009485
Study First Received: December 7, 2007
Last Updated: February 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014