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CompletedNCT00567177Updated Jul 30, 2010

Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

A Phase 4 interventional study of Restasis, Refresh Plus in Treatment of Dry Eye Disease, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-30.

Sponsored by Innovative Medical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.

02

Conditions studied

03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Innovative Medical is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Using computers more than three hours per day
  • Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
  • An abnormal confocal image of 5 or greater.

Exclusion criteria

Exclusion Criteria:

  • All corneal disorders except for tear disorders.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    1

    Drug: Restasis, Refresh Plus

  • Placebo comparator
    2

    Drug: Restasis, Refresh Plus

Interventions

  • DrugRestasis, Refresh Plus

    Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening

06

What researchers measure

Primary outcomes

  1. Dry Eye disease

    Time frame: 6 months

Secondary outcomes

  1. efficacy

    Time frame: 6 months

07

Study locations

1 site
  • Hermann Eye Center
    6400 Fannin Ste 1800, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00567177
Lead sponsor
Innovative Medical
First posted
Dec 4, 2007
Start date
Nov 2007
Completion
Apr 2008
Last update
Jul 30, 2010

Study contacts

Richard Yee, MD
principal investigator · Hermann Eye Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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