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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2010

Interventions

  • 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)
  • 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)

Arms, Groups and Cohorts

  • Active Comparator: 1.
  • Placebo Comparator: 2.

Clinical Trial Outcome Measures

Primary Measures

  • Comfort
    • Time Frame: 1 month

Secondary Measures

  • vision and wear time
    • Time Frame: 1 month

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bp Consulting, Inc
  • Provider of Information About this Clinical Study
    • Christopher Starr, MD, Weill Cornell Medical College- The New York Presbyterian Hospital
  • Overall Official(s)
    • Chris Starr, MD, Principal Investigator, The New York Presbyterian Hospital Weill Cornell Medical College

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