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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001874-12 | EudraCT Number |
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The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nepafenac | Experimental | With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. |
|
| Vehicle | Placebo Comparator | With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac Ophthalmic Suspension, 0.3% | Drug |
|
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 | BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. | Baseline to Day 14, and maintained through Day 90 |
| Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) | Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. | Day 0 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 | Baseline to Day 90 | |
| Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 | Baseline to Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Lead GCRA, Pharma | Alcon Research | Study Director |
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Of the 819 participants enrolled, 191 were exited as screen failures and 23 were discontinued prior to randomization. This reporting group includes all randomized participants (605).
Participants were recruited from 73 investigational centers located in the U.S., Europe, the Middle East, Africa, Latin America, the Caribbean, and the Asia Pacific region.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nepafenac | Nepafenac Ophthalmic Suspension, 0.3% |
| FG001 | Vehicle | Nepafenac Ophthalmic Suspension Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set, defined as all randomized participants who completed implant surgery and had at least one on-therapy postsurgical visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nepafenac | Nepafenac Ophthalmic Suspension, 0.3% |
| BG001 | Vehicle | Nepafenac Ophthalmic Suspension Vehicle |
| 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 | Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 | BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. | Full analysis set | Posted | Number | Percentage of participants | Baseline to Day 14, and maintained through Day 90 |
|
Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined.
An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
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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 | Pretreatment | All participants who consented to participate in the study prior to the initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Unit Head, Cornea and Inflammation | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Other |
Inactive ingredients used as placebo comparator |
|
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| Prednisolone acetate | Drug | 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks |
|
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| Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit | Day 7 up to any visit through Day 90 |
| Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit | Day 7 up to any visit through Day 90 |
| Death |
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| Death, prior to treatment |
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| Lost to Follow-up |
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| Physician Decision |
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| Withdrawal by Subject |
|
| Reason not provided |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Nepafenac Ophthalmic Suspension Vehicle |
|
|
|
| Primary | Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) | Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. | Full analysis set | Posted | Number | Percentage of participants | Day 0 to Day 90 |
|
|
|
|
| Secondary | Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 | Full analysis set | Posted | Number | Percentage of participants | Baseline to Day 90 |
|
|
|
| Secondary | Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 | Full analysis set | Posted | Number | Percentage of participants | Baseline to Day 60 |
|
|
|
| Secondary | Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit | Full analysis set | Posted | Number | percentage of participants | Day 7 up to any visit through Day 90 |
|
|
|
| Secondary | Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit | Full analysis set | Posted | Number | percentage of participants | Day 7 up to any visit through Day 90 |
|
|
|
| 5 |
| 819 |
| 0 |
| 819 |
| EG001 | Nepafenac | Nepafenac Ophthalmic Suspension, 0.3% | 14 | 293 | 0 | 293 |
| EG002 | Vehicle | Nepafenac Ophthalmic Suspension Vehicle | 14 | 295 | 0 | 295 |
| EG003 | Posttreatment | All participants after cessation of study treatment up to study exit | 4 | 588 | 0 | 588 |
| Angina pectoris | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Diabetic retinal oedema | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Optic ischaemic neuropathy | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Posterior capsule rupture | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Cardiac operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Cataract operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Intra-ocular injection | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Skin graft | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |