Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

Overview

To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: PEG-400
    • Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
  • Drug: Systane
    • Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily

Arms, Groups and Cohorts

  • Active Comparator: 2
    • Systane
  • Active Comparator: 1
    • PEG-400

Clinical Trial Outcome Measures

Primary Measures

  • Quality of vision
    • Time Frame: 5 months

Secondary Measures

  • Efficacy
    • Time Frame: 5 months

Participating in This Clinical Trial

Inclusion Criteria

  • Males or females > 21 years old – Scheduled to undergo bilateral LASIK – Likely to complete all study visits and able to provide informed consent Exclusion Criteria:

  • Prior or current use of topical cyclosporine within the last 1 year – Known contraindications to any study medication or ingredients – Ocular disorders – Active ocular diseases or uncontrolled systemic disease – Active ocular allergies – Complications at the time of surgery

Gender Eligibility: All

Minimum Age: 21 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
    • Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island
  • Overall Official(s)
    • Eric Donnenfeld, MD, Principal Investigator, Ophthalmic Consultants of Long Island

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