Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

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

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Bausch & LombRochesterNew YorkUnited States14609

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:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
Period Title: Overall Study
STARTED34343433343334
COMPLETED29323028323133
NOT COMPLETED5245221

Baseline Characteristics

Arm/Group Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicleTotal
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eyeTotal of all reporting groups
Overall Participants34343433343334236
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
TitleOcular Itching
DescriptionOcular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Time Frame8 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 Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
Measure Participants30333028333133
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
TitleConjunctival Redness
DescriptionConjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Time Frame8 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 Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
Measure Participants30333028333133
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
TitleCiliary Redness
DescriptionThe Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Time Frame8 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 Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
Measure Participants30333028333133
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
TitleEpiscleral Redness
DescriptionEpiscleral 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 Frame8 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 Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
Measure Participants30333028333133
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 Frame14 days
Adverse Event Reporting Description
Arm/Group Title0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Arm/Group DescriptionBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeBOL-303242-X dosed in the eyeVehicle of BOL-303242-X dosed in the eye
All Cause Mortality
0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
0.3% Once a Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/34 (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 Day2% Once a Day3% Once a Day0.3% Twice a Day2% Twice a Day3% Twice a DayVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/34 (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 reduced1/34 (2.9%) 0/34 (0%) 0/34 (0%) 0/33 (0%) 2/34 (5.9%) 0/33 (0%) 2/34 (5.9%)
Eye discharge0/34 (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 sensation0/34 (0%) 0/34 (0%) 0/34 (0%) 1/33 (3%) 0/34 (0%) 2/33 (6.1%) 0/34 (0%)
Instillation site pruritus0/34 (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 congestion0/34 (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.

Results Point of Contact

Name/TitleStudy Director
OrganizationBausch Health
Phone
Emailsusan.harris@bauschhealth.com
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