E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that: 1) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is not inferior to NEVANAC dosed three times daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction. 2) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is superior to its vehicle dosed once daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction. 3) NEVANAC dosed three times daily is superior to its vehicle dosed three times daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that: 1) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is not inferior to NEVANAC dosed three times daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction. 2) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is superior to its vehicle dosed once daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction. 3) NEVANAC dosed three times daily is superior to its vehicle dosed three times daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women of any race, 18 years or older who have cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens.
2. Study eye of patients who in the opinion of the investigator will have improvement in bestcorrected visual acuity after surgery.
3. Patients should be able to understand and sign an informed consent that has been approved by an Institutional Review Board/Independent Ethics Committee. Note: Legally authorized representative of the patient can provide informed consent.
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E.4 | Principal exclusion criteria |
1. Planned multiple procedures during cataract/IOL implantation surgery (eg. trabeculectomy, corneal transplant). Note: A planned limbal relaxing incision may be performed for the correction of astigmatism 2. Use of topical, topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit 3. Use of topical, topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit 4. Use of a topical, topical ophthalmic prostaglandin in the operative eye (eg travoprost, latanoprost, bimatoprost, tafluprost). Patients with a previous history of topical ophthalmic prostaglandin use must discontinue at least 4 days prior to surgery and through study exit. 5. Any intraocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain greater than Grade 1 in the study eye that is present during the Baseline visit 6. Previous ocular trauma to the operative eye (this includes cataract and previous intraocular surgery, where a wound is created to gain access to the anterior or posterior segments; this does not include previous laser therapy without use of an incision) 7. A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis,iridocyclitis, rubeosis iridis) in the operative eye 8. Patients who in the opinion of the investigator are at increased risk of developing postoperative macular edema (eg. diabetic retinopathy) in the operative eye 9. Currently diagnosed uncontrolled glaucoma in the operative eye 10. Lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye 11. Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye 12. A visually nonfunctional fellow eye defined as a best-corrected visual acuity ≤ 35 ETDRS letters (20/200 Snellen equivalent) or worse 13. Participation in any other investigational drug or device study within 30 days before cataract surgery 14. Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article 15. Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist: a. they are breast-feeding; b. they have a positive urine pregnancy test at screening; c. they are not willing to undergo a urine pregnancy test upon entering or exiting the study; d. they intend to become pregnant during the duration of the study; or, e. they do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal - oral, implantable, or injectable contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; IUD; or, surgical sterilization of partner)
In addition, an Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients with clinical cure at day 14. Clinical cure is defined as a score of 0 for both aqueous cells and flare.
To be defined as a clinical cure at days 1, 3 or 7, a patient must meet the definition for the primary endpoint of a clinical cure (a score of 0 for both aqueous cells and flare) at that timepoint and at all subsequent assessed timepoints.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |