Evaluation of 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: NCT01060072
• Collaborator: (none)
• Enrollment: 407
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 51.2

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loteprednol etabonate Loteprednol etabonate 0.5% ophthalmic suspension	Drug: Loteprednol etabonate; Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Placebo Comparator: Vehicle Vehicle of loteprednol etabonate ophthalmic suspension	Drug: Vehicle of Loteprednol Etabonate; Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.

Outcome Measures

Primary Outcome Measures

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

   Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

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

   Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain

Secondary Outcome Measures

1. Resolution of Anterior Chamber Cells [Visit 4-7 (postoperative day 3-18)]

   Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

2. Grade 0 Pain [Visits 4-7 (Postoperative days 3-18)]

   Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain

3. Resolution of Anterior Chamber Flare [Visit 4-7 (postoperative day 3-18)]

   Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.

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.

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 visual acuity (VA) 20/200 or worse in the non-study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	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: NCT01060072
• Other Study ID Numbers: 577
• First Posted: Feb 2, 2010
• Last Update Posted: Jan 13, 2012
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Cataract; Inflammation; Loteprednol Etabonate

Study Results

Participant Flow

Recruitment Details	This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.
Pre-assignment Detail	A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Period Title: Overall Study
STARTED	206	201
COMPLETED	204	196
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	Loteprednol Etabonate	Vehicle	Total
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.	Total of all reporting groups
Overall Participants	206	201	407
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.3 (9.66)	69.4 (9.56)	68.9 (9.62)
Sex: Female, Male (Count of Participants)
Female	124 60.2%	109 54.2%	233 57.2%
Male	82 39.8%	92 45.8%	174 42.8%
Region of Enrollment (participants) [Number]
United States	198 96.1%	193 96%	391 96.1%
Germany	8 3.9%	8 4%	16 3.9%

Outcome Measures

1. Primary Outcome

Title	Resolution of Anterior Chamber Cells.
Description	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells
Time Frame	Visit 5 (Postoperative day 8)

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) population

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Measure Participants	206	201
Number [participants]	64 31.1%	28 13.9%

2. Primary Outcome

Title	Grade 0 Pain
Description	Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
Time Frame	Visit 5 (Postoperative day 8)

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) population

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Measure Participants	206	201
Number [participants]	156 75.7%	92 45.8%

3. Secondary Outcome

Title	Resolution of Anterior Chamber Cells
Description	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells
Time Frame	Visit 4-7 (postoperative day 3-18)

Outcome Measure Data

Analysis Population Description

Intention to treat population (ITT)

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Measure Participants	206	201
Visit 4 (Postoperative Day 3)	8 3.9%	7 3.5%
Visit 5 (Postoperative Day 8)	64 31.1%	28 13.9%
Visit 6 (Postoperative Day 15)	116 56.3%	61 30.3%
Visit 7 (Postoperative Day 18)	114 55.3%	59 29.4%

4. Secondary Outcome

Title	Grade 0 Pain
Description	Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Time Frame	Visits 4-7 (Postoperative days 3-18)

Outcome Measure Data

Analysis Population Description

Intention to treat population (ITT)

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Measure Participants	206	201
Visit 4 (Postoperative Day 3)	139 67.5%	93 46.3%
Visit 5 (Postoperative Day 8)	156 75.7%	92 45.8%
Visit 6 (Postoperative Day 15)	160 77.7%	89 44.3%
Visit 7 (Postoperative Day 18)	151 73.3%	79 39.3%

5. Secondary Outcome

Title	Resolution of Anterior Chamber Flare
Description	Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.
Time Frame	Visit 4-7 (postoperative day 3-18)

Outcome Measure Data

Analysis Population Description

Intention to treat population (ITT)

Arm/Group Title	Loteprednol Etabonate	Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension	Vehicle of loteprednol etabonate ophthalmic suspension.
Measure Participants	206	201
Visit 4 (Postoperative Day 3)	93 45.1%	64 31.8%
Visit 5 (Postoperative Day 8)	134 65%	72 35.8%
Visit 6 (Postoperative Day 15)	162 78.6%	90 44.8%
Visit 7 (Postoperative Day 18)	143 69.4%	75 37.3%

Adverse Events

Time Frame	14 Days
Arm/Group Title	Loteprednol Etabonate		Vehicle
Arm/Group Description	Loteprednol etabonate 0.5% ophthalmic suspension		Vehicle of loteprednol etabonate ophthalmic suspension.
All Cause Mortality
	Loteprednol Etabonate		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Loteprednol Etabonate		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/206 (1.5%)		1/201 (0.5%)
Cardiac disorders
Myocardial infarction	1/206 (0.5%)	1	0/201 (0%)	0
Gastrointestinal disorders
Diverticulitis	1/206 (0.5%)	1	0/201 (0%)	0
Cholecystitis	1/206 (0.5%)	1	0/201 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/206 (0%)	0	1/201 (0.5%)	1
Hypokalemia	0/206 (0%)	0	1/201 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Loteprednol Etabonate		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/206 (4.9%)		24/201 (11.9%)
Eye disorders
Anterior Chamber Inflammation	7/206 (3.4%)	7	14/201 (7%)	14
Eye Pain	3/206 (1.5%)	3	10/201 (5%)	10

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.