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NCT03489941 · ClinicalTrials.gov registry record · Phase 3
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT03489941: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT03489941 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03489941, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Primary Outcome
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
Interventions
- DRUG Vehicle
- DRUG EM-100
- DRUG Zaditor®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-04-07 |
| Est. Completion | 2018-04-29 |
| Phase | Phase 3 |
What the finished NCT03489941 record still lists
NCT03489941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT03489941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03489941 about?
NCT03489941 is a clinical study titled "A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle". A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
What is the current status of trial NCT03489941?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2018-04-07. Estimated completion is 2018-04-29.
What interventions are being tested in trial NCT03489941?
The interventions under investigation include: Vehicle (DRUG), EM-100 (DRUG), Zaditor® (DRUG).
Who is sponsoring clinical trial NCT03489941?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03489941's enrollment target sits among peer trials
65 1797th of 2000 higher than 202 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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