Trial · NCT03499873

Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

NCT03499873, Phase 3, Completed, Actavis Inc.; results first posted 2021-02-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension. Trials, record NCT03499873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03499873

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
NCT number: NCT03499873
Status: Completed
Phases: Phase 3
Enrollment: 448 participants, actual
Lead sponsor: Actavis Inc.
Conditions: Cataract
Interventions: Nepafenac 0.3% Oph Susp, Placebos, Nepafenac 0.3% Oph Susp (reference)
First posted: 2018-04-17
Last updated: 2021-02-16
Results first posted: 2021-02-16

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cure at Day 14	14 days	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 severe at 0 to very severe as the grading increases.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cure at Day 14	14 days	Per-Protocol Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Cure at Day 14	Nepafenac 0.3% Opthalmic Suspension	Cure	94	Participants
Cure at Day 14	Ilevro 0.3% Opthalmic Suspension	Cure	97	Participants
Cure at Day 14	Placebo (Vehicle) Opthalmic Suspension	Cure	24	Participants
Cure at Day 14	Nepafenac 0.3% Opthalmic Suspension	Failure	50	Participants
Cure at Day 14	Ilevro 0.3% Opthalmic Suspension	Failure	46	Participants
Cure at Day 14	Placebo (Vehicle) Opthalmic Suspension	Failure	34	Participants

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nepafenac 0.3% Opthalmic Suspension	183
Overall Study	STARTED	Ilevro 0.3% Opthalmic Suspension	182
Overall Study	STARTED	Placebo (Vehicle) Opthalmic Suspension	83
Overall Study	Safety Population	Nepafenac 0.3% Opthalmic Suspension	175
Overall Study	Safety Population	Ilevro 0.3% Opthalmic Suspension	174
Overall Study	Safety Population	Placebo (Vehicle) Opthalmic Suspension	80
Overall Study	Per-Protocol Population	Nepafenac 0.3% Opthalmic Suspension	144
Overall Study	Per-Protocol Population	Ilevro 0.3% Opthalmic Suspension	143
Overall Study	Per-Protocol Population	Placebo (Vehicle) Opthalmic Suspension	58
Overall Study	Modified-Intent-to-Treat	Nepafenac 0.3% Opthalmic Suspension	170

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events222

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vertigo	Ear and labyrinth disorders	Nepafenac 0.3% Opthalmic Suspension	0	175
other	Vertigo	Ear and labyrinth disorders	Ilevro 0.3% Opthalmic Suspension	1	174
other	Vertigo	Ear and labyrinth disorders	Placebo (Vehicle) Opthalmic Suspension	0	80
other	Altered visual depth perception	Eye disorders	Nepafenac 0.3% Opthalmic Suspension	0	175
other	Altered visual depth perception	Eye disorders	Ilevro 0.3% Opthalmic Suspension	0	174
other	Altered visual depth perception	Eye disorders	Placebo (Vehicle) Opthalmic Suspension	1	80
other	Anterior chamber cell	Eye disorders	Nepafenac 0.3% Opthalmic Suspension	0	175
other	Anterior chamber cell	Eye disorders	Ilevro 0.3% Opthalmic Suspension	0	174
other	Anterior chamber cell	Eye disorders	Placebo (Vehicle) Opthalmic Suspension	1	80
other	Anterior chamber disorder	Eye disorders	Nepafenac 0.3% Opthalmic Suspension	1	175

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nepafenac 0.3% Opthalmic Suspension	0	175
Total, all-cause mortality	Ilevro 0.3% Opthalmic Suspension	0	174
Total, all-cause mortality	Placebo (Vehicle) Opthalmic Suspension	0	80
Total, other adverse events	Nepafenac 0.3% Opthalmic Suspension	54	175
Total, other adverse events	Ilevro 0.3% Opthalmic Suspension	42	174
Total, other adverse events	Placebo (Vehicle) Opthalmic Suspension	26	80
Total, serious adverse events	Nepafenac 0.3% Opthalmic Suspension	0	175
Total, serious adverse events	Ilevro 0.3% Opthalmic Suspension	0	174
Total, serious adverse events	Placebo (Vehicle) Opthalmic Suspension	0	80

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03499873

GET https://conductscience.org/api/trials/v1/NCT03499873/events?page=2

API reference For AI assistants