Trial · NCT03496467

Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract

NCT03496467, Phase 2, Completed, Mati Therapeutics Inc.; results first posted 2021-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract. Trials, record NCT03496467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496467

On this page

Trial

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

Title: Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
NCT number: NCT03496467
Status: Completed
Phases: Phase 2
Enrollment: 56 participants, actual
Lead sponsor: Mati Therapeutics Inc.
Conditions: Pain, Inflammation
Interventions: Nepafenac PPDS, Placebo PPDS
First posted: 2018-04-12
Last updated: 2021-10-12
Results first posted: 2021-10-12

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Assessment of Pain	day 14	Assessment of pain in subjects as measured by a scale of 0 - 5. Post-op pain scale: 0 represents absence of pain and 5 represents a definite, continuous unbearable ocular or periocular pain.
Secondary	Assessment of Anterior Chamber Cells	day 14	Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.
Secondary	Assessment of Flare	day 14	Anterior chamber flare is assessed using a scale of 0 - 4 with 0 representing no Tyndall effect and 4 representing Tyndall effect in anterior chamber is very intense

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Assessment of Pain	day 14	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Assessment of Anterior Chamber Cells	day 14	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Assessment of Flare	day 14	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Units
Assessment of Pain	Nepafenac PPDS	no pain	30	Participants
Assessment of Pain	Placebo PPDS	no pain	13	Participants
Assessment of Pain	Nepafenac PPDS	trace pain	2	Participants
Assessment of Pain	Placebo PPDS	trace pain	0	Participants
Assessment of Pain	Nepafenac PPDS	mild pain	2	Participants
Assessment of Pain	Placebo PPDS	mild pain	1	Participants
Assessment of Pain	Nepafenac PPDS	moderate pain	0	Participants
Assessment of Pain	Placebo PPDS	moderate pain	0	Participants
Assessment of Pain	Nepafenac PPDS	severe pain	0	Participants
Assessment of Pain	Placebo PPDS	severe pain	0	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nepafenac PPDS	38
Overall Study	STARTED	Placebo PPDS	18
Overall Study	COMPLETED	Nepafenac PPDS	34
Overall Study	COMPLETED	Placebo PPDS	14
Overall Study	NOT COMPLETED	Nepafenac PPDS	4
Overall Study	NOT COMPLETED	Placebo PPDS	4

Source ClinicalTrials.gov

Adverse events12

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	Events
other	elevated IOP	Eye disorders	Nepafenac PPDS	3	38	3
other	elevated IOP	Eye disorders	Placebo PPDS	0	18	0
other	iritis	Eye disorders	Nepafenac PPDS	2	38	2
other	iritis	Eye disorders	Placebo PPDS	1	18	1
other	Headache	Nervous system disorders	Nepafenac PPDS	1	38	1
other	Headache	Nervous system disorders	Placebo PPDS	1	18	1
other	posterior capsule rupture	Eye disorders	Nepafenac PPDS	0	38	0
other	posterior capsule rupture	Eye disorders	Placebo PPDS	1	18	1
other	Cavity, 3rd molar	General disorders	Nepafenac PPDS	1	38	1
other	Cavity, 3rd molar	General disorders	Placebo PPDS	0	18	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nepafenac PPDS	0	38
Total, all-cause mortality	Placebo PPDS	0	18
Total, other adverse events	Nepafenac PPDS	10	38
Total, other adverse events	Placebo PPDS	3	18
Total, serious adverse events	Nepafenac PPDS	0	38
Total, serious adverse events	Placebo PPDS	0	18

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 comparisons2

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

Comparison	Source
Nepafenac PPDS vs Placebo PPDS: deaths from any cause	Trial comparisons
Nepafenac PPDS vs Placebo PPDS: serious adverse events	Trial comparisons

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/NCT03496467

GET https://conductscience.org/api/trials/v1/NCT03496467/results?page=2

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