Trial Outcomes & Findings for Efficacy of Ketorolac 0.4% in Prostaglandin Suppression (NCT NCT00791323)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

Day 3

Results posted on

2011-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac 0.4% Ketorolac 0.4%	Soothe® XP Mineral Oil Emollient
Overall Study STARTED	6	3
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac 0.4% n=6 Participants Ketorolac 0.4%	Soothe® XP n=3 Participants Mineral Oil Emollient	Total n=9 Participants Total of all reporting groups
Age Continuous	30.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	33.3 years STANDARD_DEVIATION 2.5 • n=7 Participants	31.75 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Ketorolac 0.4% n=4 Participants Ketorolac 0.4%	Soothe® XP n=3 Participants Mineral Oil Emollient
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels	1027.4 Picograms per milliliter (pg/ml) Standard Deviation 429	1014.7 Picograms per milliliter (pg/ml) Standard Deviation 196.8

Adverse Events

Ketorolac 0.4%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soothe® XP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER