NCT00622037

Brief Summary

To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

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
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

February 13, 2008

Last Update Submit

February 2, 2010

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Dry Eye Signs

    4 months

Secondary Outcomes (1)

  • Visual Quality

    4 months

Study Arms (2)

1

ACTIVE COMPARATOR

PEG-400 based artificial tear

Drug: PEG-400 based artificial tear

2

ACTIVE COMPARATOR

Systane

Drug: Systane

Interventions

PEG-400 based artificial tearDRUG

Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

1
SystaneDRUG

Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
  • Physician assessment of mild-moderate dry eye
  • Patient willing to instill drops QID and complete entire length of protocol.
  • TBUT \< 10 seconds
  • BCVA of 20/30 or better

You may not qualify if:

  • Current topical cyclosporine use (Restasis)
  • Current Systane use
  • Refractive surgery within the last 6 months
  • Oral or topical corticosteroid use
  • Severe dry eye patients by physician assessment
  • current active Blepharitis
  • Oral Doxycyclines use
  • Oral Antihistamine use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Microsurgical Eye Institute

Boynton Beach, Florida, 33426, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Barry Schechter, MD

    Florida Microsurgical Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(1)