NCT00627302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 24, 2008

Status Verified

November 1, 2008

Enrollment Period

9 months

First QC Date

February 22, 2008

Last Update Submit

November 20, 2008

Conditions

Myopia

Keywords

Quality of Vision

Outcome Measures

Primary Outcomes (1)

  • Quality of vision

    5 months

Secondary Outcomes (1)

  • Efficacy

    5 months

Study Arms (2)

2

ACTIVE COMPARATOR

Systane

Drug: Systane

1

ACTIVE COMPARATOR

PEG-400

Drug: PEG-400

Interventions

PEG-400DRUG

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
SystaneDRUG

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

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females \> 21 years old
  • Scheduled to undergo bilateral LASIK
  • Likely to complete all study visits and able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of long Island

Rockville Centre, New York, 11570, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

polyethylene glycol 400

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Eric Donnenfeld, MD

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 24, 2008

Record last verified: 2008-11

Locations

US(1)