NCT00405730

Brief Summary

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
Last Updated

November 18, 2016

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

November 29, 2006

Last Update Submit

November 16, 2016

Conditions

Cataracts

Keywords

Cataracts

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients with Day 14 Cure

    Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

    Day 14

Study Arms (3)

Nepafenac

EXPERIMENTAL

One drop in the study eye 3 times daily for 23 days

Drug: Nepafenac 1mg/ml eye drops, suspension

Ketorolac Trometamol

ACTIVE COMPARATOR

One drop in the study eye 3 times daily for 23 days

Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution

Nepafenac Vehicle

PLACEBO COMPARATOR

One drop in the study eye 3 times daily for 23 days

Other: Nepafenac vehicle eye drops

Interventions

Nepafenac 1mg/ml eye drops, suspensionDRUG

One drop in the study eye 3 times daily for 23 days

Nepafenac
Ketorolac Trometamol 5 mg/ml eye drops, solutionDRUG

One drop in the study eye 3 times daily for 23 days

Ketorolac Trometamol
Nepafenac vehicle eye dropsOTHER

One drop in the study eye 3 times daily for 23 days

Nepafenac Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.

You may not qualify if:

  • Under 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

  • Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.

    PMID: 19668532RESULT

MeSH Terms

Conditions

Cataract

Interventions

nepafenacOphthalmic SolutionsSuspensionsKetorolacSolutions

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsColloidsComplex MixturesDosage FormsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

November 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 18, 2016

Record last verified: 2012-04

Locations

FR(1)