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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nepafenac 0.3% Opthalmic Suspension | Experimental | Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. |
|
| Ilevro 0.3% Opthalmic Suspension | Active Comparator | Reference product manufactured by Alcon Laboratories Inc. |
|
| Placebo (vehicle) Opthalmic Suspension | Placebo Comparator | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac 0.3% Oph Susp | Drug | Nepafenac 0.3% Ophthalmic suspension (experimental product) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nepafenac 0.3% Opthalmic Suspension | Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product) |
| FG001 | Ilevro 0.3% Opthalmic Suspension | Reference product manufactured by Alcon Laboratories Inc. Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator) |
| FG002 | Placebo (Vehicle) Opthalmic Suspension | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. Placebos: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics provided for Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Nepafenac 0.3% Opthalmic Suspension | Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product) |
| BG001 | Ilevro 0.3% Opthalmic Suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per-Protocol Population | Posted | Count of Participants | Participants | 14 days |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nepafenac 0.3% Opthalmic Suspension | Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, CE Studies | Teva Pharmaceuticals USA, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2018 | Jan 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2018 | Jan 11, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
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| Placebos | Drug | Placebo |
|
| Nepafenac 0.3% Oph Susp (reference) | Drug | Nepafenac 0.3% Ophthalmic suspension (Innovator) |
|
| Adverse Event |
|
| Physician Decision |
|
| Administrative reasons |
|
| Concomitant therapy |
|
| Miscellaneous |
|
| Investigational Product (IP) Missed dose compliance |
|
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
| BG002 | Placebo (Vehicle) Opthalmic Suspension | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. Placebos: Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iris Colour | Count of Participants | Participants |
|
| Baseline Ocular Pain Grade in Study Eye | 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. | Count of Participants | Participants |
|
| Baseline Aqueous Cells Grade in Study Eye | Grade 0-4 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance. | Count of Participants | Participants |
|
| Baseline Aqueous Flare Grade in Study Eye | Grade 0-3 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance. | Count of Participants | Participants |
|
| OG001 | Ilevro 0.3% Opthalmic Suspension | Reference product manufactured by Alcon Laboratories Inc. Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator) |
| OG002 | Placebo (Vehicle) Opthalmic Suspension | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. Placebos: Placebo |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 54 |
| 175 |
| EG001 | Ilevro 0.3% Opthalmic Suspension | Reference product manufactured by Alcon Laboratories Inc. Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator) | 0 | 174 | 0 | 174 | 42 | 174 |
| EG002 | Placebo (Vehicle) Opthalmic Suspension | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. Placebos: Placebo | 0 | 80 | 0 | 80 | 26 | 80 |
| Altered visual depth perception | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Anterior chamber cell | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Anterior chamber disorder | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Anterior chamber fibrin | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anterior chamber inflammation | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Conjunctival cyst | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Corneal disorder | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Eyelid exfoliation | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypotony of eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Keratic precipitates | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Ocular hypertention | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Ocular hypertension | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Open angle glaucoma | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Posterior capsule rupture | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitreous degeneration | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Allergy to arthropod bite | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Fibrin deposition on lens postoperative | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Hyphaema | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Iris injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.