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

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00627302
First received: February 22, 2008
Last updated: November 20, 2008
Last verified: November 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

U.S. FDA Resources

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
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

  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

No publications provided

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

Keywords provided by Bp Consulting, Inc:
Quality of Vision

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013