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NCT01212471 · ClinicalTrials.gov registry record · Phase 3

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

A Phase 3 study, sponsored by Bausch & Lomb Incorporated.

Completed
Registry status
Phase 3
Development phase
840
Enrollment target

NCT01212471: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.

NCT01212471 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 840 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01212471, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
840 participants
Enrollment target

Study Summary

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Primary Outcome

The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Interventions

  • DRUG Placebo Comparator
  • DRUG Bromfenac Ophthalmic Solution A
  • DRUG Bromfenac Ophthalmic Solution B

Trial Details

FieldValue
Enrollment Target 840 participants
Start Date 2010-09
Est. Completion 2011-12
Phase Phase 3
Bausch & Lomb Incorporated

174 total trials

What the finished NCT01212471 record still lists

NCT01212471 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.

NCT01212471 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01212471 about?

NCT01212471 is a clinical study titled "A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease". A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

What is the current status of trial NCT01212471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2010-09. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01212471?

The interventions under investigation include: Placebo Comparator (DRUG), Bromfenac Ophthalmic Solution A (DRUG), Bromfenac Ophthalmic Solution B (DRUG).

Who is sponsoring clinical trial NCT01212471?

This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01212471's enrollment target sits among peer trials

840 392nd of 2000 higher than 1,607 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01212471, the US trial registry maintained by the National Library of Medicine. NCT01212471 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.