Nevanac 3-Month Safety Study With QID Dosing | NCT00332774

Studies
Nevanac 3-Month Safety Study With QID Dosing

NCT00332774

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

149Actual

Phase

Phase 3

Conditions

Cataract

Interventions

Nepafenac ophthalmic solution 0.1%
Ketorolac Tromethamine ophthalmic solution 0.4%
Nepafenac ophthalmic suspension vehicle

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

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

Mar 1, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Description Module

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.

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

149Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Nevanac	Experimental	Drug: Nepafenac ophthalmic solution 0.1%
Acular	Active Comparator	Drug: Ketorolac Tromethamine ophthalmic solution 0.4%
Vehicle	Placebo Comparator	Other: Nepafenac ophthalmic suspension vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nepafenac ophthalmic solution 0.1%	Drug	1 drop 4 times daily for 90 days	Nevanac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular thickness

Secondary Outcomes

Measure	Description	Time Frame
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 exclusion criteria may apply

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
Stephen Lane	Medical Monitor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon for Trial Locations		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011184	Postoperative Period

Ancestor Terms

ID	Term
D059035	Perioperative Period
D013514	Surgical Procedures, Operative
D005791	Patient Care
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided