Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
Condition: Cataract
MeSH terms: Cataract
Intervention: Nepafenac 0.3% Oph Susp; Placebos; Nepafenac 0.3% Oph Susp (reference)
Intervention description: Nepafenac 0.3% Ophthalmic suspension (experimental product); Placebo; Nepafenac 0.3% Ophthalmic suspension (Innovator)
Intervention MeSH terms: Nepafenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or non-pregnant, non-lactating females, 18 years of age or older who have a
             cataract and are expected to undergo cataract extraction.

          2. 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.

          3. 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.

          4. Study subjects should be literate and willing to complete the subject diary regularly
             as directed.

          5. Study subjects must be in good health and free from any clinically significant disease
             apart from indication under study.

          6. 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.

          7. 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.

          8. 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.

          9. 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.

         10. Study subjects must be willing to refrain from using any other treatments other than
             the investigational product.

        Exclusion Criteria:

          1. Females who are pregnant, breast feeding, or planning a pregnancy during the course of
             the study and for 30 days after last study dose.

          2. Females of childbearing potential who do not agree to utilize an adequate form of
             contraception.

          3. Current or past history of severe hepatic or renal impairment, uncontrolled diabetes
             mellitus, rheumatoid arthritis or bleeding tendencies.

          4. 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.

          5. 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.

          6. Congenital ocular anomaly, e.g., aniridia or congenital cataract.

          7. Iris atrophy in the operative eye.

          8. Current corneal abnormalities that would prevent accurate IOP readings with the
             Goldmann applanation tonometer.

          9. Nonfunctional nonoperative eye (visual acuity of 20/200 or worse Snellen or ETDRS).

         10. Known hypersensitivity to any component of nepafenac therapy or to other nonsteroidal
             anti-inflammatory drug (NSAID).

         11. Use within one week prior to baseline of: 1) contact lens, or 2) topical, ophthalmic
             or systemic NSAID.

         12. 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).

         13. 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.

         14. Use within six months prior to baseline of intravitreal or subtenon injection of
             ophthalmic corticosteroid.

         15. Underwent within six months prior to baseline any complicated intraocular surgery or
             repeat ocular surgeries (e.g., cataract surgery).

         16. Underwent within twelve months prior to baseline: refractive surgery, filtering
             surgery or laser surgery for IOP reduction.

         17. History or presence of significant alcoholism or drug abuse in the past one year.

         18. History or presence of significant smoking (more than 20 cigarettes or any other
             equivalent tobacco product/day).

         19. History of hematologic disorders other than mild anemia.

         20. Severe, unstable, or uncontrolled cardiovascular or pulmonary disease.

         21. Therapy with an investigational agent within the past 30 days prior to screening.

         22. Clinically significant hematologic and / or biochemical abnormalities based on
             laboratory testing.

         23. Subjects who are in the investigator's best judgment at risk of visual field or visual
             acuity worsening as a consequence of participation in trial.

         24. Use of any prescribed medication during last two weeks or OTC medicinal products
             during the last one week preceding the first dosing that results in drug-drug
             interaction with the study drug.

         25. Major illness, as per investigator discretion, during 3 months before screening.

         26. Subjects who are employees of site or CRO or sponsor or immediate family of employees.