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NCT01459588 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
A Phase 3 study of Dry Eye Syndromes, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
- 1
- Study location
NCT01459588: Completed Phase 3 study of Dry Eye Syndromes, sponsored by Allergan.
NCT01459588 is a Phase 3 study of Dry Eye Syndromes that has completed, run by Allergan. The registered enrollment target is 315 participants, below the 396-participant average among 17 other Dry Eye Syndromes trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459588, a Phase 3 study of Dry Eye Syndromes, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
Primary Outcome
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Conditions Studied
Interventions
- DRUG Carboxymethylcellulose Based Eye Drop Formulation A
- DRUG Carboxymethylcellulose Based Eye Drop Formulation B
- DRUG Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
- DRUG Carboxymethylcellulose Based Lubricant Eye Drops
Study Locations (1)
California
- - Petaluma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2011-10-01 |
| Est. Completion | 2012-02-15 |
| Phase | Phase 3 |
What the finished NCT01459588 record still lists
NCT01459588 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, below the 396-participant average among 17 other Dry Eye Syndromes trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Dry Eye Syndromes appearing as the primary indexed condition, and to 4 interventions - of which Carboxymethylcellulose Based Eye Drop Formulation A is the first listed.
NCT01459588 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01459588 about?
NCT01459588 is a clinical study titled "Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease". This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
What is the current status of trial NCT01459588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2011-10-01. Estimated completion is 2012-02-15.
What conditions does trial NCT01459588 study?
This clinical trial studies the following conditions: Dry Eye Syndromes.
What interventions are being tested in trial NCT01459588?
The interventions under investigation include: Carboxymethylcellulose Based Eye Drop Formulation A (DRUG), Carboxymethylcellulose Based Eye Drop Formulation B (DRUG), Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (DRUG), Carboxymethylcellulose Based Lubricant Eye Drops (DRUG).
Who is sponsoring clinical trial NCT01459588?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01459588 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01459588's enrollment target sits among peer trials
315 2nd of 17 the highest of 17 other Dry Eye Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Syndromes 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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ACCURATE Study for Subjects With Dry Eyes
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