Trial Outcomes & Findings for A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery (NCT NCT00524264)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

248 participants

Primary outcome timeframe

Day 14

Results posted on

2009-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac Solution	Vehicle Solution
Overall Study STARTED	164	84
Overall Study COMPLETED	144	57
Overall Study NOT COMPLETED	20	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac Solution n=164 Participants	Vehicle Solution n=84 Participants	Total n=248 Participants Total of all reporting groups
Age, Customized <45 years	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Age, Customized Between 45 and 65 years	53 participants n=5 Participants	33 participants n=7 Participants	86 participants n=5 Participants
Age, Customized >65 years	108 participants n=5 Participants	49 participants n=7 Participants	157 participants n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	49 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	35 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Population: Modified Intent-to-Treat Population

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)

Outcome measures

Outcome measures
Measure	Ketorolac Solution n=149 Participants	Vehicle Solution n=78 Participants
Resolution of Post Operative Inflammation	46.3 % of participants with a score of 0	25.6 % of participants with a score of 0

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population

Measured on a scale of 0-4 (0 = none, 4 = intolerable)

Outcome measures

Outcome measures
Measure	Ketorolac Solution n=152 Participants	Vehicle Solution n=78 Participants
Ocular Pain	75.0 % of participants with a score of 0	41.0 % of participants with a score of 0

SECONDARY outcome

Timeframe: Day 0

Population: Modified Intent-to-Treat Population

Pupil area post-irrigation and aspiration

Outcome measures

Outcome measures
Measure	Ketorolac Solution n=154 Participants	Vehicle Solution n=78 Participants
Mean Pupil Area	41.8 millimeters squared (mm²) Standard Deviation 12.6	41.1 millimeters squared (mm²) Standard Deviation 14.0

POST_HOC outcome

Timeframe: Change from baseline at Day 14

Population: Modified Intent-to-Treat Population

Patients with ≥ 3 line improvement in visual acuity

Outcome measures

Outcome measures
Measure	Ketorolac Solution n=153 Participants	Vehicle Solution n=78 Participants
Visual Acuity	59.5 Percentage of patients with ≥ 3 lines	46.2 Percentage of patients with ≥ 3 lines

Adverse Events

Ketorolac Solution

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Vehicle Solution

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketorolac Solution	Vehicle Solution
Cardiac disorders Angina Unstable	0.64% 1/157	0.00% 0/81
Cardiac disorders Cardiac Arrest	0.64% 1/157	0.00% 0/81
Cardiac disorders Coronary Artery Occlusion	0.64% 1/157	0.00% 0/81
Cardiac disorders Coronary Artery Disease	0.00% 0/157	1.2% 1/81

Other adverse events

Other adverse events
Measure	Ketorolac Solution	Vehicle Solution
Eye disorders Foreign body sensation in eyes	5.1% 8/157	6.2% 5/81
Eye disorders Iritis	5.1% 8/157	6.2% 5/81
Eye disorders Eye Pain	4.5% 7/157	18.5% 15/81
Eye disorders Conjunctival Hyperemia	1.9% 3/157	14.8% 12/81
Eye disorders Photophobia	1.3% 2/157	9.9% 8/81
Nervous system disorders Headache	5.7% 9/157	6.2% 5/81
Eye disorders Intraocular Pressure Increased	5.7% 9/157	2.5% 2/81

Additional Information

Therapeutic Area Head

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