Cataract Extraction
Conditions
Brief summary
This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery
Interventions
DRUGketorolac eye drops
1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing cataract surgery
Exclusion criteria
* Uncontrolled ocular disease in cataract surgery eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Post Operative Inflammation | Day 14 | Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Pain | Day 1 | Measured on a scale of 0-4 (0 = none, 4 = intolerable) |
| Mean Pupil Area | Day 0 | Pupil area post-irrigation and aspiration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Solution | 176 |
| Vehicle Solution | 87 |
| Total | 263 |
Baseline characteristics
| Characteristic | Ketorolac Solution | Vehicle Solution | Total |
|---|---|---|---|
| Age, Customized <45 years | 4 participants | 3 participants | 7 participants |
| Age, Customized >65 years | 116 participants | 52 participants | 168 participants |
| Age, Customized Between 45 and 65 years | 56 participants | 32 participants | 88 participants |
| Sex: Female, Male Female | 101 Participants | 51 Participants | 152 Participants |
| Sex: Female, Male Male | 75 Participants | 36 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 68 / — | 57 / — |
| serious Total, serious adverse events | 1 / — | 0 / — |
Outcome results
Primary
Resolution of Post Operative Inflammation
Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)
Time frame: Day 14
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Solution | Resolution of Post Operative Inflammation | 58.0 % of participants with a score of 0 |
| Vehicle Solution | Resolution of Post Operative Inflammation | 27.3 % of participants with a score of 0 |
Secondary
Mean Pupil Area
Pupil area post-irrigation and aspiration
Time frame: Day 0
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Solution | Mean Pupil Area | 37.9 millimeters squared (mm²) | Standard Deviation 12 |
| Vehicle Solution | Mean Pupil Area | 36.5 millimeters squared (mm²) | Standard Deviation 13.5 |
Secondary
Ocular Pain
Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Time frame: Day 1
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Solution | Ocular Pain | 70.0 % of participants with a score of 0 |
| Vehicle Solution | Ocular Pain | 38.5 % of participants with a score of 0 |
Post Hoc
Visual Acuity
Patients with ≥ 3 line improvement in visual acuity
Time frame: Change from baseline at Day 14
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Solution | Visual Acuity | 56.9 Percentage of patients with ≥ 3 lines |
| Vehicle Solution | Visual Acuity | 36.3 Percentage of patients with ≥ 3 lines |