Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01289431
• Collaborator: (none)
• Enrollment: 236
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 121.8

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Allergic	Drug: Mapracorat; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mapracorat	Drug: Mapracorat; administered daily to each eye for 2 weeks following allergen challenge using a CAC model
Placebo Comparator: Mapracorat Vehicle	Drug: Vehicle; administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Outcome Measures

Primary Outcome Measures

1. Ocular Itching [8 hours]

   Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.

2. Conjunctival Redness [8 hours]

   Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.

Secondary Outcome Measures

1. Ciliary Redness [8 hours]

   The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.

2. Episcleral Redness [8 hours]

   Episcleral redness was evaluated by the Investigator using a 0-4 scale with half unit increments allowed. A lower score is indicative of less episcleral redness.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• positive history of ocular allergies and a positive skin test reaction

• positive bilateral CAC reaction

Exclusion Criteria:

• have known contraindications or sensitivities to the use of any of the study medications(s) or their components.

• have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.

• had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;

• a known history of retinal detachment, diabetic retinopathy, or active retinal disease;

• the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.

• use of any disallowed medications during the period indicated prior to Visit 1 and during the study.

• have planned surgery during the trial period or within 30 days after.

• have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1

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: Rabia Ozden, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01289431
• Other Study ID Numbers: 685
• First Posted: Feb 3, 2011
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic

Study Results

Participant Flow

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye
Period Title: Overall Study
STARTED	34	34	34	33	34	33	34
COMPLETED	29	32	30	28	32	31	33
NOT COMPLETED	5	2	4	5	2	2	1

Baseline Characteristics

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle	Total
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye	Total of all reporting groups
Overall Participants	34	34	34	33	34	33	34	236
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (10.41)	35.4 (13.62)	37.7 (16.10)	31.4 (11.46)	36.0 (13.82)	32.4 (12.03)	35.1 (13.61)	35.0 (13.13)
Sex: Female, Male (Count of Participants)
Female	18 52.9%	19 55.9%	21 61.8%	17 51.5%	17 50%	14 42.4%	15 44.1%	121 51.3%
Male	16 47.1%	15 44.1%	13 38.2%	16 48.5%	17 50%	19 57.6%	19 55.9%	115 48.7%

Outcome Measures

1. Primary Outcome

Title	Ocular Itching
Description	Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye
Measure Participants	30	33	30	28	33	31	33
Mean (Standard Deviation) [score on a scale]	1.71 (1.212)	1.34 (0.757)	2.11 (1.196)	2.06 (0.880)	1.65 (0.804)	1.58 (0.842)	2.28 (0.985)

2. Primary Outcome

Title	Conjunctival Redness
Description	Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye
Measure Participants	30	33	30	28	33	31	33
Mean (Standard Deviation) [score on a scale]	2.05 (0.757)	1.56 (0.723)	2.01 (0.791)	1.82 (0.779)	1.72 (0.828)	1.81 (0.757)	2.14 (0.631)

3. Secondary Outcome

Title	Ciliary Redness
Description	The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye
Measure Participants	30	33	30	28	33	31	33
Mean (Standard Deviation) [score on a scale]	1.88 (0.903)	1.39 (0.860)	1.89 (0.875)	1.60 (0.850)	1.58 (0.915)	1.65 (0.751)	2.02 (0.780)

4. Secondary Outcome

Title	Episcleral Redness
Description	Episcleral redness was evaluated by the Investigator using a 0-4 scale with half unit increments allowed. A lower score is indicative of less episcleral redness.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm/Group Title	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	BOL-303242-X dosed in the eye	Vehicle of BOL-303242-X dosed in the eye
Measure Participants	30	33	30	28	33	31	33
Mean (Standard Deviation) [score on a scale]	2.11 (0.739)	1.56 (0.735)	2.07 (0.763)	1.85 (0.805)	1.79 (0.868)	1.97 (0.772)	2.25 (0.632)

Adverse Events

Time Frame	14 days
Arm/Group Title	0.3% Once a Day		2% Once a Day		3% Once a Day		0.3% Twice a Day		2% Twice a Day		3% Twice a Day		Vehicle
Arm/Group Description	BOL-303242-X dosed in the eye		BOL-303242-X dosed in the eye		BOL-303242-X dosed in the eye		BOL-303242-X dosed in the eye		BOL-303242-X dosed in the eye		BOL-303242-X dosed in the eye		Vehicle of BOL-303242-X dosed in the eye
All Cause Mortality
	0.3% Once a Day		2% Once a Day		3% Once a Day		0.3% Twice a Day		2% Twice a Day		3% Twice 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
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	0.3% Once a Day		2% Once a Day		3% Once a Day		0.3% Twice a Day		2% Twice a Day		3% Twice 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
Total	0/34 (0%)		0/34 (0%)		0/34 (0%)		0/33 (0%)		0/34 (0%)		0/33 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	0.3% Once a Day		2% Once a Day		3% Once a Day		0.3% Twice a Day		2% Twice a Day		3% Twice 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
Total	1/34 (2.9%)		0/34 (0%)		4/34 (11.8%)		1/33 (3%)		2/34 (5.9%)		2/33 (6.1%)		7/34 (20.6%)
Eye disorders
Visual acuity reduced	1/34 (2.9%)		0/34 (0%)		0/34 (0%)		0/33 (0%)		2/34 (5.9%)		0/33 (0%)		2/34 (5.9%)
Eye discharge	0/34 (0%)		0/34 (0%)		0/34 (0%)		0/33 (0%)		0/34 (0%)		0/33 (0%)		2/34 (5.9%)
General disorders
Instillation site abnormal sensation	0/34 (0%)		0/34 (0%)		0/34 (0%)		1/33 (3%)		0/34 (0%)		2/33 (6.1%)		0/34 (0%)
Instillation site pruritus	0/34 (0%)		0/34 (0%)		2/34 (5.9%)		0/33 (0%)		0/34 (0%)		0/33 (0%)		2/34 (5.9%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/34 (0%)		0/34 (0%)		2/34 (5.9%)		0/33 (0%)		0/34 (0%)		0/33 (0%)		1/34 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.