NCT00332774

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Shorter than P25 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

February 1, 2006

Completed
4 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

June 1, 2006

Last Update Submit

March 1, 2012

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Macular thickness

Secondary Outcomes (1)

  • contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Study Arms (3)

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

Nepafenac ophthalmic solution 0.1%DRUG

1 drop 4 times daily for 90 days

Nevanac
Ketorolac Tromethamine ophthalmic solution 0.4%DRUG

1 drop 4 times daily for 90 days

Acular
Nepafenac ophthalmic suspension vehicleOTHER
Also known as: 1 drop 4 times daily for 14 days after surgery
Vehicle

Eligibility Criteria

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

You may qualify if:

  • Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.

You may not qualify if:

  • Under 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephen Lane

    Medical Monitor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)