Nevanac 3-Month Safety Study With QID Dosing

A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332774

Enrollment

149

Registered

2006-06-02

Start date

2006-02-28

Completion date

2006-12-31

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Interventions

DRUGNepafenac ophthalmic solution 0.1%

1 drop 4 times daily for 90 days

DRUGKetorolac Tromethamine ophthalmic solution 0.4%

1 drop 4 times daily for 90 days

OTHERNepafenac ophthalmic suspension vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Under 10 * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Macular thickness	—

Secondary

Measure	Time frame
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026