Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00905450
• Collaborator: (none)
• Enrollment: 415
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 37.8

Study Details

Study Description

Brief Summary

This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Inflammation	Drug: BOL-303242-X; Drug: Vehicle for BOL-303242-X	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 415 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BOL-303242-X BOL-303242-X (Mapracorat)	Drug: BOL-303242-X; Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.; Other Names: Mapracorat
Placebo Comparator: Vehicle Vehicle for BOL-303242-X (Mapracorat)	Drug: Vehicle for BOL-303242-X; Medication instilled into the study eye, subjects randomized to various drug dose schedules.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. [8 days]

   Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0.

Secondary Outcome Measures

1. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. [8 days]

   A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.

• Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.

• Subjects who are candidates for cataract surgery.

• Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.

• Subjects must be able and willing to comply with all treatment and follow- up procedures.

Exclusion Criteria:

• Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.

• Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

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

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, MS, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00905450
• Other Study ID Numbers: 588
• First Posted: May 20, 2009
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Bausch & Lomb Incorporated: Surgery
• Additional relevant MeSH terms: Cataract; Inflammation

Study Results

Participant Flow

Arm/Group Title	1% Twice a Day	2% Once a Day	2% Twice a Day	2% Four Times a Day	3% Once a Day	3% Twice a Day	3% Four Times a Day	Vehicle
Arm/Group Description	BOL-303242-X ophthalmic suspension 1% Twice a Day	BOL-303242-X ophthalmic suspension 2% Once a Day	BOL-303242-X ophthalmic suspension 2% Twice a Day	BOL-303242-X ophthalmic suspension 2% Four times a Day	BOL-303242-X ophthalmic suspension 3% Once a Day	BOL-303242-X ophthalmic suspension 3% Twice a Day	BOL-303242-X ophthalmic suspension 3% Four times a Day	Vehicle for BOL-303242-X ophthalmic suspension
Period Title: Overall Study
STARTED	60	28	28	60	59	60	60	60
COMPLETED	59	27	28	60	59	58	58	59
NOT COMPLETED	1	1	0	0	0	2	2	1

Baseline Characteristics

Arm/Group Title	1% Twice a Day	2% Once a Day	2% Twice a Day	2% Four Times a Day	3% Once a Day	3% Twice a Day	3% Four Times a Day	Vehicle	Total
Arm/Group Description	BOL-303242-X ophthalmic suspension 1% Twice a Day	BOL-303242-X ophthalmic suspension 2% Once a Day	BOL-303242-X ophthalmic suspension 2% Twice a Day	BOL-303242-X ophthalmic suspension 2% Four times a Day	BOL-303242-X ophthalmic suspension 3% Once a Day	BOL-303242-X ophthalmic suspension 3% Twice a Day	BOL-303242-X ophthalmic suspension 3% Four times a Day	Vehicle for BOL-303242-X ophthalmic suspension	Total of all reporting groups
Overall Participants	60	28	28	60	59	60	60	60	415
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.4 (12.0)	67.9 (10.9)	68.9 (10.5)	69.5 (7.1)	68.2 (10.8)	67.3 (10.7)	68.5 (10.3)	67.1 (10.8)	67.8 (10.4)
Sex: Female, Male (Count of Participants)
Female	33 55%	15 53.6%	15 53.6%	34 56.7%	30 50.8%	32 53.3%	31 51.7%	32 53.3%	222 53.5%
Male	27 45%	13 46.4%	13 46.4%	26 43.3%	29 49.2%	28 46.7%	29 48.3%	28 46.7%	193 46.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
Description	Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0.
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1% Twice a Day	2% Once a Day	2% Twice a Day	2% Four Times a Day	3% Once a Day	3% Twice a Day	3% Four Times a Day	Vehicle
Arm/Group Description	BOL-303242-X ophthalmic suspension 1% Twice a Day	BOL-303242-X ophthalmic suspension 2% Once a Day	BOL-303242-X ophthalmic suspension 2% Twice a Day	BOL-303242-X ophthalmic suspension 2% Four times a Day	BOL-303242-X ophthalmic suspension 3% Once a Day	BOL-303242-X ophthalmic suspension 3% Twice a Day	BOL-303242-X ophthalmic suspension 3% Four times a Day	Vehicle for BOL-303242-X ophthalmic suspension
Measure Participants	60	28	28	60	59	60	60	60
Count of Participants [Participants]	35 58.3%	19 67.9%	15 53.6%	47 78.3%	42 71.2%	45 75%	42 70%	30 50%

2. Secondary Outcome

Title	Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
Description	A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1% Twice a Day	2% Once a Day	2% Twice a Day	2% Four Times a Day	3% Once a Day	3% Twice a Day	3% Four Times a Day	Vehicle
Arm/Group Description	BOL-303242-X ophthalmic suspension 1% Twice a Day	BOL-303242-X ophthalmic suspension 2% Once a Day	BOL-303242-X ophthalmic suspension 2% Twice a Day	BOL-303242-X ophthalmic suspension 2% Four times a Day	BOL-303242-X ophthalmic suspension 3% Once a Day	BOL-303242-X ophthalmic suspension 3% Twice a Day	BOL-303242-X ophthalmic suspension 3% Four times a Day	Vehicle for BOL-303242-X ophthalmic suspension
Measure Participants	60	28	28	60	59	60	60	60
Count of Participants [Participants]	15 25%	6 21.4%	7 25%	18 30%	21 35.6%	23 38.3%	18 30%	11 18.3%

Adverse Events

Time Frame	18 days
Arm/Group Title	1% Twice a Day		2% Once a Day		2% Twice a Day		2% Four Times a Day		3% Once a Day		3% Twice a Day		3% Four Times a Day		Vehicle
Arm/Group Description	BOL-303242-X ophthalmic suspension 1% Twice a Day		BOL-303242-X ophthalmic suspension 2% Once a Day		BOL-303242-X ophthalmic suspension 2% Twice a Day		BOL-303242-X ophthalmic suspension 2% Four times a Day		BOL-303242-X ophthalmic suspension 3% Once a Day		BOL-303242-X ophthalmic suspension 3% Twice a Day		BOL-303242-X ophthalmic suspension 3% Four times a Day		Vehicle for BOL-303242-X ophthalmic suspension
All Cause Mortality
	1% Twice a Day		2% Once a Day		2% Twice a Day		2% Four Times a Day		3% Once a Day		3% Twice a Day		3% Four Times a Day		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	1% Twice a Day		2% Once a Day		2% Twice a Day		2% Four Times a Day		3% Once a Day		3% Twice a Day		3% Four Times a Day		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/28 (0%)		0/28 (0%)		0/60 (0%)		1/59 (1.7%)		1/60 (1.7%)		0/60 (0%)		0/60 (0%)
Eye disorders
Cystoid macular edema	0/60 (0%)		0/28 (0%)		0/28 (0%)		0/60 (0%)		1/59 (1.7%)		0/60 (0%)		0/60 (0%)		0/60 (0%)
Subretinal neovascularization	0/60 (0%)		0/28 (0%)		0/28 (0%)		0/60 (0%)		0/59 (0%)		1/60 (1.7%)		0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	1% Twice a Day		2% Once a Day		2% Twice a Day		2% Four Times a Day		3% Once a Day		3% Twice a Day		3% Four Times a Day		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/60 (71.7%)		20/28 (71.4%)		7/28 (25%)		18/60 (30%)		11/59 (18.6%)		25/60 (41.7%)		21/60 (35%)		37/60 (61.7%)
Eye disorders
Eye pain	7/60 (11.7%)		4/28 (14.3%)		2/28 (7.1%)		0/60 (0%)		3/59 (5.1%)		2/60 (3.3%)		2/60 (3.3%)		6/60 (10%)
Photophobia	7/60 (11.7%)		4/28 (14.3%)		0/28 (0%)		1/60 (1.7%)		1/59 (1.7%)		4/60 (6.7%)		4/60 (6.7%)		5/60 (8.3%)
AC Inflammation	2/60 (3.3%)		1/28 (3.6%)		0/28 (0%)		2/60 (3.3%)		1/59 (1.7%)		3/60 (5%)		2/60 (3.3%)		4/60 (6.7%)
Ocular hyperaemia	5/60 (8.3%)		1/28 (3.6%)		0/28 (0%)		1/60 (1.7%)		1/59 (1.7%)		2/60 (3.3%)		3/60 (5%)		2/60 (3.3%)
Lacrimation increased	3/60 (5%)		2/28 (7.1%)		0/28 (0%)		2/60 (3.3%)		1/59 (1.7%)		2/60 (3.3%)		2/60 (3.3%)		2/60 (3.3%)
Corneal edema	2/60 (3.3%)		4/28 (14.3%)		1/28 (3.6%)		1/60 (1.7%)		0/59 (0%)		1/60 (1.7%)		1/60 (1.7%)		3/60 (5%)
Foreign body sensation in eyes	4/60 (6.7%)		0/28 (0%)		0/28 (0%)		1/60 (1.7%)		0/59 (0%)		2/60 (3.3%)		3/60 (5%)		2/60 (3.3%)
Dry eye	3/60 (5%)		2/28 (7.1%)		0/28 (0%)		1/60 (1.7%)		0/59 (0%)		2/60 (3.3%)		1/60 (1.7%)		0/60 (0%)
Eye pruritis	4/60 (6.7%)		2/28 (7.1%)		0/28 (0%)		0/60 (0%)		1/59 (1.7%)		1/60 (1.7%)		1/60 (1.7%)		0/60 (0%)
Iritis	0/60 (0%)		0/28 (0%)		1/28 (3.6%)		1/60 (1.7%)		1/59 (1.7%)		1/60 (1.7%)		1/60 (1.7%)		4/60 (6.7%)
Conjunctival hyperemia	1/60 (1.7%)		0/28 (0%)		1/28 (3.6%)		0/60 (0%)		1/59 (1.7%)		0/60 (0%)		0/60 (0%)		3/60 (5%)
AC Flare	0/60 (0%)		0/28 (0%)		2/28 (7.1%)		0/60 (0%)		0/59 (0%)		0/60 (0%)		0/60 (0%)		3/60 (5%)
Eye inflammation	0/60 (0%)		0/28 (0%)		0/28 (0%)		0/60 (0%)		0/59 (0%)		3/60 (5%)		0/60 (0%)		0/60 (0%)
Ciliary hyperemia	1/60 (1.7%)		0/28 (0%)		0/28 (0%)		2/60 (3.3%)		0/59 (0%)		3/60 (5%)		0/60 (0%)		0/60 (0%)
Investigations
Intraocular pressure increased	2/60 (3.3%)		0/28 (0%)		0/28 (0%)		2/60 (3.3%)		0/59 (0%)		1/60 (1.7%)		1/60 (1.7%)		3/60 (5%)
Nervous system disorders
Headache	2/60 (3.3%)		0/28 (0%)		0/28 (0%)		4/60 (6.7%)		1/59 (1.7%)		1/60 (1.7%)		0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.