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

November 20, 2008 updated by: Bp Consulting, Inc
To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rockville Centre, New York, United States, 11570
        • Ophthalmic Consultants of Long Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of vision
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bp Consulting, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 24, 2008

Last Update Submitted That Met QC Criteria

November 20, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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