A Phase 4 interventional study of Ketorolac 0.4% and Lubricating Eye Drop in Inflammation, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-23.
Sponsored by Allergan · Phase 4, Interventional, and Basic science
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
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Exclusion Criteria:
Ketorolac 0.4%
Drug: Ketorolac 0.4%
Mineral Oil Emollient
Drug: Lubricating Eye Drop
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
Also known as: Acular LS™
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
Also known as: Soothe® XP
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
| Milestone | Ketorolac 0.4% | Soothe® XP |
|---|---|---|
| Started | 6 | 3 |
| Completed | 6 | 3 |
| Not completed | 0 | 0 |
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).
| Picograms per milliliter (pg/ml) | Ketorolac 0.4% | Soothe® XP |
|---|---|---|
| Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels | 1027.4 ± 429 | 1014.7 ± 196.8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketorolac 0.4% | — | 0/6 (0%) | 0/6 (0%) |
| Soothe® XP | — | 0/3 (0%) | 0/3 (0%) |
| Age Continuous(years) | Ketorolac 0.4% | Soothe® XP | Total |
|---|---|---|---|
| Mean | 30.2 ± 9.7 | 33.3 ± 2.5 | 31.75 ± 6.1 |
| Sex: Female, Male(Participants) | Ketorolac 0.4% | Soothe® XP | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 1 | 2 | 3 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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