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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