Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
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|ClinicalTrials.gov Identifier: NCT03499873|
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Nepafenac 0.3% Oph Susp Drug: Placebos Drug: Nepafenac 0.3% Oph Susp (reference)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double Masked, Placebo Controlled, Parallel Group, Bioequivalence Study to Evaluate the Clinical Equivalence and Safety of Nepafenac 0.3% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Actavis LLC) With IlevroTM (Nepafenac Ophthalmic Suspension), 0.3% of Alcon Laboratories, Inc. for the Treatment of Pain and Inflammation Associated With Cataract Surgery.|
|Actual Study Start Date :||March 28, 2018|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||December 18, 2018|
Experimental: Nepafenac 0.3% Opthalmic Suspension
Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.
Drug: Nepafenac 0.3% Oph Susp
Nepafenac 0.3% Ophthalmic suspension (experimental product)
Active Comparator: Ilevro 0.3% Opthalmic Suspension
Reference product manufactured by Alcon Laboratories Inc.
Drug: Nepafenac 0.3% Oph Susp (reference)
Nepafenac 0.3% Ophthalmic suspension (Innovator)
Placebo Comparator: Placebo (vehicle) Opthalmic Suspension
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
- Subjects with cure at Day 14 [ Time Frame: 14 days following treatment ]Proportion of subjects with cure at Day 14 defined as a score of 0 for aqueous cells, a score of 0 for aqueous flare and a score of no more than 3 for pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499873
|United States, Texas|
|Key-Whitman Eye Center|
|Dallas, Texas, United States, 75243|