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

NCT ID: NCT00627302

Last Updated: 2008-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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Conditions

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Myopia

Keywords

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Quality of Vision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Systane

Group Type ACTIVE_COMPARATOR

Systane

Intervention Type DRUG

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

PEG-400

Group Type ACTIVE_COMPARATOR

PEG-400

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bp Consulting, Inc

NETWORK

Sponsor Role lead

Responsible Party

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Ophthalmic Consultants of Long Island

Principal Investigators

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Eric Donnenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

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Ophthalmic Consultants of long Island

Rockville Centre, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5353

Identifier Type: -

Identifier Source: org_study_id