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NCT00926185 · ClinicalTrials.gov registry record · Phase 2

A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

A Phase 2 study, sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
230
Enrollment target

NCT00926185: Completed Phase 2 study, sponsored by Shire.

NCT00926185 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 230 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00926185, a Phase 2 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
230 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Primary Outcome

Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score i

Interventions

  • DRUG Placebo
  • DRUG Lifitegrast

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2009-08-03
Est. Completion 2010-02-18
Phase Phase 2
Shire

245 total trials

What the finished NCT00926185 record still lists

NCT00926185 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00926185 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00926185 about?

NCT00926185 is a clinical study titled "A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)". The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

What is the current status of trial NCT00926185?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2009-08-03. Estimated completion is 2010-02-18.

What interventions are being tested in trial NCT00926185?

The interventions under investigation include: Placebo (DRUG), Lifitegrast (DRUG).

Who is sponsoring clinical trial NCT00926185?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00926185's enrollment target sits among peer trials

230 257th of 2000 higher than 1,737 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00926185, the US trial registry maintained by the National Library of Medicine. NCT00926185 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.