Cataract Extraction, Inflammation, Pain
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
Ophthalmic drops, BID pre- and post-operation, 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 | 164 |
| Vehicle Solution | 84 |
| Total | 248 |
Baseline characteristics
| Characteristic | Total | Ketorolac Solution | Vehicle Solution |
|---|---|---|---|
| Age, Customized <45 years | 5 participants | 3 participants | 2 participants |
| Age, Customized >65 years | 157 participants | 108 participants | 49 participants |
| Age, Customized Between 45 and 65 years | 86 participants | 53 participants | 33 participants |
| Sex: Female, Male Female | 141 Participants | 92 Participants | 49 Participants |
| Sex: Female, Male Male | 107 Participants | 72 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / — | 52 / — |
| serious Total, serious adverse events | 2 / — | 1 / — |
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 | 46.3 % of participants with a score of 0 |
| Vehicle Solution | Resolution of Post Operative Inflammation | 25.6 % 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 | 41.8 millimeters squared (mm²) | Standard Deviation 12.6 |
| Vehicle Solution | Mean Pupil Area | 41.1 millimeters squared (mm²) | Standard Deviation 14 |
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 | 75.0 % of participants with a score of 0 |
| Vehicle Solution | Ocular Pain | 41.0 % 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 | 59.5 Percentage of patients with ≥ 3 lines |
| Vehicle Solution | Visual Acuity | 46.2 Percentage of patients with ≥ 3 lines |