Inflammation
Conditions
Brief summary
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
Interventions
DRUGKetorolac 0.4%
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
DRUGLubricating Eye Drop
One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo phakic IOL implantation
Exclusion criteria
* History of intraocular surgery in the operative eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels | Day 3 | The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac 0.4% Ketorolac 0.4% | 6 |
| Soothe® XP Mineral Oil Emollient | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Ketorolac 0.4% | Soothe® XP | Total |
|---|---|---|---|
| Age Continuous | 30.2 years STANDARD_DEVIATION 9.7 | 33.3 years STANDARD_DEVIATION 2.5 | 31.75 years STANDARD_DEVIATION 6.1 |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels
The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).
Time frame: Day 3
Population: Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac 0.4% | Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels | 1027.4 Picograms per milliliter (pg/ml) | Standard Deviation 429 |
| Soothe® XP | Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels | 1014.7 Picograms per milliliter (pg/ml) | Standard Deviation 196.8 |