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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.

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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

FieldValue
Enrollment Target 448 participants
Start Date 2018-03-28
Est. Completion 2018-12-18
Phase Phase 3
Actavis

79 total trials

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.

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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Source: ClinicalTrials.gov NCT03499873, the US trial registry maintained by the National Library of Medicine. NCT03499873 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.