Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS... | NCT00333255

Studies
Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

NCT00333255

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 8, 2009Estimated

Enrollment

267Actual

Phase

Phase 3

Conditions

Cataract

Interventions

Nepafenac Ophthalmic Suspension, 0.1%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2009

Last Update Posted Date

Jul 8, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

267Actual

Name	Type	Description	Arm Group Labels	Other Names
Nepafenac Ophthalmic Suspension, 0.1%	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

Under 10

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Maxwell	Study Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lehmann Eye Center		Nacogdoches	Texas	76134	United States

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases