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NCT05579730 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

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

Completed
Registry status
Phase 3
Development phase
188
Enrollment target

NCT05579730: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.

NCT05579730 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05579730, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
188 participants
Enrollment target

Study Summary

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

Primary Outcome

Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.

Interventions

  • DRUG Vehicle
  • DRUG Brimonidine Tartrate 0.025%
  • DRUG Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%
  • DRUG Ketotifen Fumarate 0.035%

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2022-10-12
Est. Completion 2023-07-22
Phase Phase 3
Bausch & Lomb Incorporated

174 total trials

What the finished NCT05579730 record still lists

NCT05579730 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 4 interventions - of which Vehicle is the first listed.

NCT05579730 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05579730 about?

NCT05579730 is a clinical study titled "Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis". To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

What is the current status of trial NCT05579730?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2022-10-12. Estimated completion is 2023-07-22.

What interventions are being tested in trial NCT05579730?

The interventions under investigation include: Vehicle (DRUG), Brimonidine Tartrate 0.025% (DRUG), Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% (DRUG), Ketotifen Fumarate 0.035% (DRUG).

Who is sponsoring clinical trial NCT05579730?

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 NCT05579730's enrollment target sits among peer trials

188 1408th of 2000 higher than 591 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 NCT05579730, the US trial registry maintained by the National Library of Medicine. NCT05579730 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.