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CompletedNCT00567983Updated Sep 25, 2008

Topical Cyclosporine and Disease Progression

A Phase 4 interventional study of Restasis and Endura in Disease Progression, Disease Severity and Staining, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-25.

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

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

02

Conditions studied

  • Disease Progression
  • Disease Severity
  • Staining
  • Schirmers
  • OSDI

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03

In context

Disease Progression

544 studies on the registry are indexed under Disease Progression; 144 are open to participants now.

This study's planned enrollment of 80 is close to the median of 87 across 266 interventional studies indexed under Disease Progression.

Browse Disease Progression 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Mild to Moderate dry eye symptoms

Exclusion criteria

Exclusion Criteria:

  • Current use of Restasis
05

Study design

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

Study arms

  • Active comparator
    1.

    Drug: Restasis

  • Placebo comparator
    2.

    Drug: Endura

Interventions

  • DrugRestasis

    Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

  • DrugEndura

    Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

06

What researchers measure

Primary outcomes

  1. Disease Severity

    Time frame: 1 yr

Secondary outcomes

  1. Staining

    Time frame: 1 yr

07

Study locations

1 site
  • Lakeside Eye Clinic
    Chicago, Illinois 60641, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00567983
Lead sponsor
Innovative Medical
First posted
Dec 5, 2007
Start date
Dec 2007
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Sep 25, 2008

Study contacts

Sanjay Rao
principal investigator · Lakeside Eye Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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