Trial Outcomes & Findings for A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery (NCT NCT00521456)

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

263 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	176	87
Overall Study COMPLETED	163	59
Overall Study NOT COMPLETED	13	28

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=176 Participants	Vehicle Solution n=87 Participants	Total n=263 Participants Total of all reporting groups
Age, Customized <45 years	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Age, Customized Between 45 and 65 years	56 participants n=5 Participants	32 participants n=7 Participants	88 participants n=5 Participants
Age, Customized >65 years	116 participants n=5 Participants	52 participants n=7 Participants	168 participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	51 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	36 Participants n=7 Participants	111 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=169 Participants	Vehicle Solution n=77 Participants
Resolution of Post Operative Inflammation	58.0 % of participants with a score of 0	27.3 % 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=170 Participants	Vehicle Solution n=78 Participants
Ocular Pain	70.0 % of participants with a score of 0	38.5 % 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=173 Participants	Vehicle Solution n=81 Participants
Mean Pupil Area	37.9 millimeters squared (mm²) Standard Deviation 12.0	36.5 millimeters squared (mm²) Standard Deviation 13.5

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=167 Participants	Vehicle Solution n=80 Participants
Visual Acuity	56.9 Percentage of patients with ≥ 3 lines	36.3 Percentage of patients with ≥ 3 lines

Adverse Events

Ketorolac Solution

Serious events: 1 serious events

Other events: 68 other events

Deaths: 0 deaths

Vehicle Solution

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketorolac Solution	Vehicle Solution
Injury, poisoning and procedural complications Post procedural haemorrhage	0.58% 1/173	0.00% 0/82

Other adverse events

Other adverse events
Measure	Ketorolac Solution	Vehicle Solution
Eye disorders Conjunctival Hyperaemia	6.9% 12/173	13.4% 11/82
Eye disorders Anterior chamber cell	6.9% 12/173	7.3% 6/82
Eye disorders Anterior chamber flare	6.4% 11/173	7.3% 6/82
Eye disorders Corneal edema	5.2% 9/173	9.8% 8/82
Eye disorders Eye pain	4.0% 7/173	12.2% 10/82
Eye disorders Iritis	3.5% 6/173	8.5% 7/82
Eye disorders Photophobia	0.58% 1/173	9.8% 8/82
Investigations Intraocular pressure increased	5.8% 10/173	1.2% 1/82

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