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Nepafenac Once Daily for Macular Edema - Study 1

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Proliferative Diabetic Retinopathy; Cataract

Intervention: Nepafenac Ophthalmic Suspension, 0.3% (Drug); Nepafenac vehicle (Other); Prednisolone acetate ophthalmic suspension (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Abhijit Narvekar, MS, MBBS, Study Director, Affiliation: Alcon Research

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.

Clinical Details

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

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

Primary outcome: Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 14 and maintained through Day 90

Secondary outcome:

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

Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 90

Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 60

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 after randomization and prior to the Day

90 postoperative study visit or through study exit;

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

implantation surgery;

- 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.

Locations and Contacts

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: June 2013
Last updated: May 27, 2015

Page last updated: August 23, 2015

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