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

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ClinicalTrials.gov Identifier: NCT00627302
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Bp Consulting, Inc

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

Condition or disease Intervention/treatment Phase
Myopia Drug: PEG-400 Drug: Systane Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : February 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
Systane
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
Active Comparator: 1
PEG-400
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



Primary Outcome Measures :
  1. Quality of vision [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627302


Locations
United States, New York
Ophthalmic Consultants of long Island
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Bp Consulting, Inc
Investigators
Principal Investigator: Eric Donnenfeld, MD Ophthalmic Consultants of Long Island

Responsible Party: Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier: NCT00627302     History of Changes
Other Study ID Numbers: 5353
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008

Keywords provided by Bp Consulting, Inc:
Quality of Vision