Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01010633
• Collaborator: (none)
• Enrollment: 406
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 45.3

Study Details

Study Description

Brief Summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Pain	Drug: Vehicle of Loteprednol Etabonate; Drug: Loteprednol Etabonate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 406 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loteprednol Etabonate Loteprednol etabonate	Drug: Loteprednol Etabonate; 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Placebo Comparator: Vehicle Vehicle of loteprednol etabonate	Drug: Vehicle of Loteprednol Etabonate; 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.

Outcome Measures

Primary Outcome Measures

1. Resolution of Anterior Chamber Cells (ACC). [Visit 5 (Postoperative day 8)]

   Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.

2. Grade 0 Pain [Visit 5 (Postoperative Day 8)]

   Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

Secondary Outcome Measures

1. Resolution of Anterior Chamber Cells. [At visits 4-7- postoperative day 3, 8,15 & 18]

   Study eyes with complete resolution of anterior chamber cells (ACC)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects who are at least 18 years of age.

• Subjects who are candidates for routine, uncomplicated cataract surgery.

• Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

• Subjects who have known hypersensitivity or contraindication to the study drug or components.

• Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.

• Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.

• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb, Inc.	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Laura Trusso, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01010633
• Other Study ID Numbers: 576
• First Posted: Nov 10, 2009
• Last Update Posted: Jan 9, 2012
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Inflammation; Loteprednol Etabonate

Study Results

Participant Flow

Recruitment Details	This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
Pre-assignment Detail	406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.

Arm/Group Title	Loteprednol	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5%	Vehicle of loteprednol etabonate
Period Title: Overall Study
STARTED	203	203
COMPLETED	199	198
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Loteprednol	Vehicle	Total
Arm/Group Description	Loteprednol etabonate 0.5%	Vehicle of loteprednol etabonate	Total of all reporting groups
Overall Participants	203	203	406
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.3 (8.73)	69.0 (9.80)	69.1 (9.27)
Sex: Female, Male (Count of Participants)
Female	109 53.7%	122 60.1%	231 56.9%
Male	94 46.3%	81 39.9%	175 43.1%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	0 0%	1 0.5%	1 0.2%
Asian	2 1%	3 1.5%	5 1.2%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.2%
Black or African American	20 9.9%	16 7.9%	36 8.9%
White	176 86.7%	182 89.7%	358 88.2%
Other	4 2%	1 0.5%	5 1.2%

Outcome Measures

1. Primary Outcome

Title	Resolution of Anterior Chamber Cells (ACC).
Description	Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Time Frame	Visit 5 (Postoperative day 8)

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population

Arm/Group Title	Loteprednol	Vehicle
Arm/Group Description	Loteprednol Etabonate 0.5%	Vehicle of Loteprednol Etabonate
Measure Participants	203	203
Measure Eyes	203	203
Number [Eyes]	62	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Loteprednol, Vehicle
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.3
	Confidence Interval	(2-Sided) 95%; 5.7 to 22.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Resolution of Anterior Chamber Cells.
Description	Study eyes with complete resolution of anterior chamber cells (ACC)
Time Frame	At visits 4-7- postoperative day 3, 8,15 & 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Loteprednol	Vehicle
Arm/Group Description	Loteprednol Etabonate 0.5%	Vehicle of Loteprednol Etabonate
Measure Participants	203	203
Visit 4	17	11
Visit 5	62	33
Visit 6	102	44
Visit 7	96	45

3. Primary Outcome

Title	Grade 0 Pain
Description	Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Time Frame	Visit 5 (Postoperative Day 8)

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT)

Arm/Group Title	Loteprednol	Vehicle
Arm/Group Description	Loteprednol Etabonate 0.5%	Vehicle of Loteprednol Etabonate
Measure Participants	203	203
Measure Eyes	203	203
Number [Eyes]	148	85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Loteprednol, Vehicle
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.0
	Confidence Interval	(2-Sided) 95%; 21.4 to 40.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Visit 3 post-operative day 1 thru visit 7 postoperative day 18
Arm/Group Title	Loteprednol		Vehicle
Arm/Group Description	Loteprednol etabonate 0.5%		Vehicle of loteprednol etabonate
All Cause Mortality
	Loteprednol		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Loteprednol		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/203 (0.5%)		2/203 (1%)
Cardiac disorders
Heart Failure	0/203 (0%)	0	1/203 (0.5%)	1
Eye disorders
Cystoid Macular Edema	1/203 (0.5%)	1	1/203 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Bronchitis	0/203 (0%)	0	1/203 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Loteprednol		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/203 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.