NCT00333255

Brief Summary

The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

June 1, 2006

Last Update Submit

July 7, 2009

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).

Secondary Outcomes (1)

  • Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation

Interventions

Nepafenac Ophthalmic Suspension, 0.1%DRUG

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • planned cataract extraction with posterior chamber intraocular lens implantation

You may not qualify if:

  • Under 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehmann Eye Center

Nacogdoches, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Andrew Maxwell

    Study Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

US(1)