Trial Outcomes & Findings for Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension (NCT NCT03499873)
NCT ID: NCT03499873
Last Updated: 2021-02-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
448 participants
Primary outcome timeframe
14 days
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
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)
|
Ilevro 0.3% Opthalmic Suspension
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
|
Placebo (Vehicle) Opthalmic Suspension
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Placebos: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
183
|
182
|
83
|
|
Overall Study
Safety Population
|
175
|
174
|
80
|
|
Overall Study
Per-Protocol Population
|
144
|
143
|
58
|
|
Overall Study
Modified-Intent-to-Treat
|
170
|
168
|
77
|
|
Overall Study
COMPLETED
|
163
|
162
|
56
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
27
|
Reasons for withdrawal
| Measure |
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)
|
Ilevro 0.3% Opthalmic Suspension
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
|
Placebo (Vehicle) Opthalmic Suspension
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Placebos: Placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
1
|
|
Overall Study
Subjects condition worsened
|
0
|
3
|
11
|
|
Overall Study
Adverse Event
|
8
|
3
|
6
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Administrative reasons
|
0
|
1
|
0
|
|
Overall Study
Concomitant therapy
|
5
|
4
|
7
|
|
Overall Study
Miscellaneous
|
1
|
2
|
2
|
|
Overall Study
Investigational Product (IP) Missed dose compliance
|
1
|
1
|
0
|
Baseline Characteristics
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
Baseline characteristics by cohort
| Measure |
Nepafenac 0.3% Opthalmic Suspension
n=175 Participants
Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.
Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)
|
Ilevro 0.3% Opthalmic Suspension
n=174 Participants
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
|
Placebo (Vehicle) Opthalmic Suspension
n=80 Participants
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Placebos: Placebo
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 9.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Iris Colour
Blue
|
38 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Iris Colour
Green
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Iris Colour
Grey
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Iris Colour
Hazel
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Iris Colour
Brown
|
97 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Iris Colour
Black
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 0 (less severe)
|
172 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
424 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Grade 5 (most severe)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Ocular Pain Grade in Study Eye
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Grade 0 (least severe)
|
173 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
426 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Grade 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Grade 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Grade 4 (most severe)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Cells Grade in Study Eye
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Baseline Aqueous Flare Grade in Study Eye
Grade 0 (least severe)
|
173 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
426 Participants
n=4 Participants
|
|
Baseline Aqueous Flare Grade in Study Eye
Grade 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Flare Grade in Study Eye
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Flare Grade in Study Eye
Grade 3 (most severe)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Aqueous Flare Grade in Study Eye
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Per-Protocol Population
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.
Outcome measures
| Measure |
Nepafenac 0.3% Opthalmic Suspension
n=144 Participants
Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.
Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)
|
Ilevro 0.3% Opthalmic Suspension
n=143 Participants
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
|
Placebo (Vehicle) Opthalmic Suspension
n=58 Participants
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Placebos: Placebo
|
|---|---|---|---|
|
Cure at Day 14
Cure
|
94 Participants
|
97 Participants
|
24 Participants
|
|
Cure at Day 14
Failure
|
50 Participants
|
46 Participants
|
34 Participants
|
Adverse Events
Nepafenac 0.3% Opthalmic Suspension
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Ilevro 0.3% Opthalmic Suspension
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo (Vehicle) Opthalmic Suspension
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nepafenac 0.3% Opthalmic Suspension
n=175 participants at risk
Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.
Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)
|
Ilevro 0.3% Opthalmic Suspension
n=174 participants at risk
Reference product manufactured by Alcon Laboratories Inc.
Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)
|
Placebo (Vehicle) Opthalmic Suspension
n=80 participants at risk
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Placebos: Placebo
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Anterior chamber disorder
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Anterior chamber fibrin
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Anterior chamber inflammation
|
2.3%
4/175 • 1 month
|
1.1%
2/174 • 1 month
|
2.5%
2/80 • 1 month
|
|
Eye disorders
Blepharitis
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Chalazion
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Conjunctival cyst
|
1.1%
2/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Conjunctival haemorrhage
|
0.57%
1/175 • 1 month
|
1.1%
2/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Conjunctival hyperaemia
|
0.57%
1/175 • 1 month
|
1.1%
2/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Conjunctivitis allergic
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Corneal disorder
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Corneal oedema
|
1.1%
2/175 • 1 month
|
1.1%
2/174 • 1 month
|
5.0%
4/80 • 1 month
|
|
Eye disorders
Eye discharge
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Eye inflammation
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Eye irritation
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
2.5%
2/80 • 1 month
|
|
Eye disorders
Eye pain
|
2.3%
4/175 • 1 month
|
1.7%
3/174 • 1 month
|
5.0%
4/80 • 1 month
|
|
Eye disorders
Eye pruritus
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Eyelid exfoliation
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Foreign body sensation in eyes
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Macular oedema
|
1.1%
2/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Ocular discomfort
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
3.8%
3/80 • 1 month
|
|
Eye disorders
Ocular hypertention
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Open angle glaucoma
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Photophobia
|
0.57%
1/175 • 1 month
|
0.57%
1/174 • 1 month
|
3.8%
3/80 • 1 month
|
|
Eye disorders
Photopsia
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Posterior capsule opacification
|
2.3%
4/175 • 1 month
|
0.57%
1/174 • 1 month
|
2.5%
2/80 • 1 month
|
|
Eye disorders
Posterior capsule rupture
|
0.00%
0/175 • 1 month
|
1.7%
3/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Vision blurred
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Eye disorders
Vitreous degeneration
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Vitreous detachment
|
1.1%
2/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Eye disorders
Vitreous floaters
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
General disorders
Fatigue
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
General disorders
Inflammation
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
General disorders
Oedema peripheral
|
0.57%
1/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
General disorders
Sensation of foreign body
|
0.57%
1/175 • 1 month
|
1.1%
2/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Immune system disorders
Drug hypersensitivity
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Infections and infestations
Bronchitis
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Infections and infestations
Sinusitis
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Infections and infestations
Urinary tract infection
|
2.3%
4/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.57%
1/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Fibrin deposition on lens postoperative
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Iris injury
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
1.1%
2/175 • 1 month
|
0.00%
0/174 • 1 month
|
2.5%
2/80 • 1 month
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.57%
1/175 • 1 month
|
1.1%
2/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Investigations
Blood glucose increased
|
2.9%
5/175 • 1 month
|
3.4%
6/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Investigations
Blood pressure increased
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Investigations
Intraocular pressure increased
|
4.6%
8/175 • 1 month
|
1.7%
3/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/175 • 1 month
|
2.3%
4/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Nervous system disorders
Dizziness
|
0.57%
1/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Nervous system disorders
Headache
|
4.6%
8/175 • 1 month
|
4.6%
8/174 • 1 month
|
10.0%
8/80 • 1 month
|
|
Nervous system disorders
Migraine
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Nervous system disorders
Sciatica
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.57%
1/175 • 1 month
|
0.00%
0/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/175 • 1 month
|
0.57%
1/174 • 1 month
|
0.00%
0/80 • 1 month
|
|
Vascular disorders
Flushing
|
0.00%
0/175 • 1 month
|
0.00%
0/174 • 1 month
|
1.2%
1/80 • 1 month
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER