Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Bp Consulting, Inc Identifier:
First received: February 22, 2008
Last updated: November 20, 2008
Last verified: November 2008

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

Condition Intervention Phase
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:

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
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
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


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00627302

United States, New York
Ophthalmic Consultants of long Island
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Bp Consulting, Inc
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 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 processed this record on March 03, 2015