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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00524264
• Collaborator: (none)
• Enrollment: 248
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 41.2

Study Details

Study Description

Brief Summary

This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract Extraction; Pain; Inflammation	Drug: ketorolac	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 248 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ketorolac; Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day. Placebo
Placebo Comparator: 2	Drug: ketorolac; Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day. Placebo

Outcome Measures

Primary Outcome Measures

1. Resolution of Post Operative Inflammation [Day 14]

   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)

Secondary Outcome Measures

1. Ocular Pain [Day 1]

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

2. Mean Pupil Area [Day 0]

   Pupil area post-irrigation and aspiration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing cataract surgery

Exclusion Criteria:

• Uncontrolled ocular disease in cataract surgery eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00524264
• Other Study ID Numbers: 191578-005
• First Posted: Sep 3, 2007
• Last Update Posted: Oct 1, 2009
• Last Verified: Aug 1, 2009

• Additional relevant MeSH terms: Cataract; Inflammation; Ketorolac

Study Results

Participant Flow

Arm/Group Title	Ketorolac Solution	Vehicle Solution
Arm/Group Description
Period Title: Overall Study
STARTED	164	84
COMPLETED	144	57
NOT COMPLETED	20	27

Baseline Characteristics

Arm/Group Title	Ketorolac Solution	Vehicle Solution	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	164	84	248
Age, Customized (participants) [Number]
<45 years	3 1.8%	2 2.4%	5 2%
Between 45 and 65 years	53 32.3%	33 39.3%	86 34.7%
>65 years	108 65.9%	49 58.3%	157 63.3%
Sex: Female, Male (Count of Participants)
Female	92 56.1%	49 58.3%	141 56.9%
Male	72 43.9%	35 41.7%	107 43.1%

Outcome Measures

1. Primary Outcome

Title	Resolution of Post Operative Inflammation
Description	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)
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Ketorolac Solution	Vehicle Solution
Arm/Group Description
Measure Participants	149	78
Number [% of participants with a score of 0]	46.3 28.2%	25.6 30.5%

2. Secondary Outcome

Title	Ocular Pain
Description	Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Ketorolac Solution	Vehicle Solution
Arm/Group Description
Measure Participants	152	78
Number [% of participants with a score of 0]	75.0 45.7%	41.0 48.8%

3. Secondary Outcome

Title	Mean Pupil Area
Description	Pupil area post-irrigation and aspiration
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Ketorolac Solution	Vehicle Solution
Arm/Group Description
Measure Participants	154	78
Mean (Standard Deviation) [millimeters squared (mm²)]	41.8 (12.6)	41.1 (14.0)

4. Post-Hoc Outcome

Title	Visual Acuity
Description	Patients with ≥ 3 line improvement in visual acuity
Time Frame	Change from baseline at Day 14

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Ketorolac Solution	Vehicle Solution
Arm/Group Description
Measure Participants	153	78
Number [Percentage of patients with ≥ 3 lines]	59.5	46.2

Adverse Events

Arm/Group Title	Ketorolac Solution		Vehicle Solution
Arm/Group Description
All Cause Mortality
	Ketorolac Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketorolac Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/ (NaN)		1/ (NaN)
Cardiac disorders
Angina Unstable	1/157 (0.6%)		0/81 (0%)
Cardiac Arrest	1/157 (0.6%)		0/81 (0%)
Coronary Artery Occlusion	1/157 (0.6%)		0/81 (0%)
Coronary Artery Disease	0/157 (0%)		1/81 (1.2%)
Other (Not Including Serious) Adverse Events
	Ketorolac Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/ (NaN)		52/ (NaN)
Eye disorders
Foreign body sensation in eyes	8/157 (5.1%)		5/81 (6.2%)
Iritis	8/157 (5.1%)		5/81 (6.2%)
Eye Pain	7/157 (4.5%)		15/81 (18.5%)
Conjunctival Hyperemia	3/157 (1.9%)		12/81 (14.8%)
Photophobia	2/157 (1.3%)		8/81 (9.9%)
Intraocular Pressure Increased	9/157 (5.7%)		2/81 (2.5%)
Nervous system disorders
Headache	9/157 (5.7%)		5/81 (6.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.