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Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision
This study has been completed.
Sponsored by: Bp Consulting, Inc
Information provided by: Bp Consulting, Inc
ClinicalTrials.gov Identifier: NCT00627302
  Purpose

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


Condition Intervention Phase
Myopia
 Drug: PEG-400
Drug: Systane
 Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Quality of vision [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
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
1: Active Comparator
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Ophthalmic Consultants of Long Island ( Eric Donnenfeld, MD )
Study ID Numbers: 5353
Study First Received: February 22, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00627302  
Health Authority: United States: Institutional Review Board

Keywords provided by Bp Consulting, Inc:
Quality of Vision

Study placed in the following topic categories:
Lacerations
Myopia

ClinicalTrials.gov processed this record on January 16, 2009



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