Nepafenac Once Daily for Macular Edema - Study 2

Cataract Clinical Trial

Official title:

Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872611
• Other study ID #: C-12-071
• Secondary ID: 2013-001874-12
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2013
• Last updated: May 27, 2015
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;

• History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;

• Best-corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;

• Understand and sign an informed consent document;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pre-existing macular edema in the study eye;

• History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;

• Planned cataract surgery in the fellow eye prior to the Day 90 postoperative study visit or through study exit;

• Planned multiple procedures for the study eye during the cataract/intraocular lens;

• Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.

• Participation in any other clinical study within 30 days of the screening visit;

• Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Non-Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Nepafenac Ophthalmic Suspension, 0.3%

Other:
• Nepafenac Vehicle
Inactive ingredients used as placebo comparator

Drug:
• Prednisolone acetate ophthalmic suspension
1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with best-corrected visual acuity (BCVA) improvement of = 15 letters from preoperative baseline to Day 14 and maintained through Day 90	As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts	Baseline, up to Day 90	No
Secondary	Proportion of subjects who develop macular edema (defined as = 30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery	As measured with Spectral Domain Ocular Coherence Tomography (SD-OCT)	Baseline, up to Day 90	No
Secondary	Proportion of subjects with BCVA improvement of = 15 letters from preoperative baseline to Day 90	As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts	Baseline, Day 90	No
Secondary	Proportion of subjects with BCVA improvement of = 15 letters from preoperative baseline to Day 60	As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts	Baseline, Day 60	No