Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

NCT03499873 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TCTM/NEPA/2017
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Cure at Day 14

  Number of participants that achieved cure at Day 14 defined as a score of 0 for aqueous cells (Grade 0-4 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance), a score of 0 for aqueous flare (Grade 0-3 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance) and a score of no more than 3 for pain (Grade 0-5 a positive sensation of the eye, including foreign body sensation, stabbing, throbbing or aching). The scoring indicates from less severe at 0 to very severe as the grading increases.

  14 days

Study Arms (3)

Nepafenac 0.3% Opthalmic Suspension

EXPERIMENTAL

Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.

Drug: Nepafenac 0.3% Oph Susp

Ilevro 0.3% Opthalmic Suspension

ACTIVE COMPARATOR

Reference product manufactured by Alcon Laboratories Inc.

Drug: Nepafenac 0.3% Oph Susp (reference)

Placebo (vehicle) Opthalmic Suspension

PLACEBO COMPARATOR

Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.

Drug: Placebos

Interventions

Nepafenac 0.3% Oph Susp DRUG

Nepafenac 0.3% Ophthalmic suspension (experimental product)

Nepafenac 0.3% Opthalmic Suspension

Placebos DRUG

Placebo

Placebo (vehicle) Opthalmic Suspension

Nepafenac 0.3% Oph Susp (reference) DRUG

Nepafenac 0.3% Ophthalmic suspension (Innovator)

Ilevro 0.3% Opthalmic Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-lactating females, 18 years of age or older who have a cataract and are expected to undergo cataract extraction.
• No aqueous cells, no visible aqueous flare and no significant ocular pain in the selected eye noted during the Screening visit by slit-lamp examination.
• Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form. In addition, study subjects must sign a HIPAA authorization, if applicable.
• Study subjects should be literate and willing to complete the subject diary regularly as directed.
• Study subjects must be in good health and free from any clinically significant disease apart from indication under study.
• Females of child bearing potential (WOCBP\*) must not be pregnant or lactating at baseline visit (as documented by a negative urine pregnancy test with a minimum sensitivity of 25 IU/L or equivalent units of beta-human chorionic gonadotropin (Beta-HCG) at screening and urine pregnancy at baseline.
• Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of IP. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (Medroxyprogesterone acetate-stabilized for at least 3 months); vaginal contraceptive; contraceptive implant; double barrier methods (e.g. condom and spermicide); Nuvaring vaginal hormonal birth control, IUD, or abstinence with a second method of birth control should the subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
• All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration (to 30 days after the last administration of study drug). Please see acceptable forms for "Female" birth control above. Abstinence is an acceptable method of birth control for males.
• Study subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
• Study subjects must be willing to refrain from using any other treatments other than the investigational product.

You may not qualify if:

• Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose.
• Females of childbearing potential who do not agree to utilize an adequate form of contraception.
• Current or past history of severe hepatic or renal impairment, uncontrolled diabetes mellitus, rheumatoid arthritis or bleeding tendencies.
• Current or history within two months prior to baseline of clinically significant ocular disease, e.g., corneal denervation, corneal epithelial defects, severe dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
• In the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise.
• Congenital ocular anomaly, e.g., aniridia or congenital cataract.
• Iris atrophy in the operative eye.
• Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
• Nonfunctional nonoperative eye (visual acuity of 20/200 or worse Snellen or ETDRS).
• Known hypersensitivity to any component of nepafenac therapy or to other nonsteroidal anti-inflammatory drug (NSAID).
• Use within one week prior to baseline of: 1) contact lens, or 2) topical, ophthalmic or systemic NSAID.
• Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, 2) topical corticosteroid, or 3) medications which may prolong bleeding time (per investigator discretion and primary care physician approval to discontinue use for surgery).
• Use within one month prior to baseline of: 1) systemic corticosteroid, 2) high-dose salicylate therapy, or 3) topical ophthalmic prostaglandin analogs, e.g., bimatoprost, latanoprost or travoprost.
• Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
• Underwent within six months prior to baseline any complicated intraocular surgery or repeat ocular surgeries (e.g., cataract surgery).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals USA, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 17, 2018
• Study Start: March 28, 2018
• Primary Completion: October 31, 2018
• Study Completion: December 18, 2018
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Locations

US (1)