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NCT03499873 · ClinicalTrials.gov registry record · Phase 3
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
NCT03499873: Completed Phase 3 study, sponsored by Actavis.
NCT03499873 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 448 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03499873, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
Study Summary
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.
Primary Outcome
Number of participants that achieved cure at Day 14 defined as a score of 0 for aqueous cells (Grade 0-4 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance), a score of 0 for aqueous flare (Grade 0-3 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance) and a score of no more than 3 for pain (Grade 0-5 a positive sensation of the eye, including foreign body sensation, stabbing, throbbing or aching). The scoring indicates from less sever
Interventions
- DRUG Placebos
- DRUG Nepafenac 0.3% Oph Susp
- DRUG Nepafenac 0.3% Oph Susp (reference)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2018-03-28 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 3 |
What the finished NCT03499873 record still lists
NCT03499873 is an interventional study that assigns participants to a tested intervention. The registered 448 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 (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebos is the first listed.
NCT03499873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03499873 about?
NCT03499873 is a clinical study titled "Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension". A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of A...
What is the current status of trial NCT03499873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2018-03-28. Estimated completion is 2018-12-18.
What interventions are being tested in trial NCT03499873?
The interventions under investigation include: Placebos (DRUG), Nepafenac 0.3% Oph Susp (DRUG), Nepafenac 0.3% Oph Susp (reference) (DRUG).
Who is sponsoring clinical trial NCT03499873?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03499873's enrollment target sits among peer trials
448 864th of 2000 higher than 1,137 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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