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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapracorat | Experimental |
| |
| Mapracorat Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapracorat | Drug | administered daily to each eye for 2 weeks following allergen challenge using a CAC model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching. | 8 hours |
| Conjunctival Redness | Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness | The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness. | 8 hours |
| Episcleral Redness | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabia Ozden, OD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% Once a Day | BOL-303242-X dosed in the eye |
| FG001 | 2% Once a Day | BOL-303242-X dosed in the eye |
| FG002 | 3% Once a Day | BOL-303242-X dosed in the eye |
| FG003 | 0.3% Twice a Day | BOL-303242-X dosed in the eye |
| FG004 | 2% Twice a Day | BOL-303242-X dosed in the eye |
| FG005 | 3% Twice a Day | BOL-303242-X dosed in the eye |
| FG006 | Vehicle | Vehicle of BOL-303242-X dosed in the eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% Once a Day | BOL-303242-X dosed in the eye |
| BG001 | 2% Once a Day | BOL-303242-X dosed in the eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Itching | Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching. | Participants with results at the 8 hour timepoint are included, with no imputation for missing data. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.3% Once a Day | BOL-303242-X dosed in the eye |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C546413 | R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol |
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| Vehicle | Drug | administered daily to each eye for 2 weeks following allergen challenge using a CAC model |
|
| 8 hours |
| BG002 |
| 3% Once a Day |
BOL-303242-X dosed in the eye |
| BG003 | 0.3% Twice a Day | BOL-303242-X dosed in the eye |
| BG004 | 2% Twice a Day | BOL-303242-X dosed in the eye |
| BG005 | 3% Twice a Day | BOL-303242-X dosed in the eye |
| BG006 | Vehicle | Vehicle of BOL-303242-X dosed in the eye |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
BOL-303242-X dosed in the eye |
| OG003 | 0.3% Twice a Day | BOL-303242-X dosed in the eye |
| OG004 | 2% Twice a Day | BOL-303242-X dosed in the eye |
| OG005 | 3% Twice a Day | BOL-303242-X dosed in the eye |
| OG006 | Vehicle | Vehicle of BOL-303242-X dosed in the eye |
|
|
| Primary | Conjunctival Redness | Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness. | Participants with results at the 8 hour timepoint are included, with no imputation for missing data. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| Secondary | Ciliary Redness | The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness. | Participants with results at the 8 hour timepoint are included, with no imputation for missing data. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| Secondary | Episcleral Redness | 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. | Participants with results at the 8 hour timepoint are included, with no imputation for missing data. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | 2% Once a Day | BOL-303242-X dosed in the eye | 0 | 34 | 0 | 34 |
| EG002 | 3% Once a Day | BOL-303242-X dosed in the eye | 0 | 34 | 4 | 34 |
| EG003 | 0.3% Twice a Day | BOL-303242-X dosed in the eye | 0 | 33 | 1 | 33 |
| EG004 | 2% Twice a Day | BOL-303242-X dosed in the eye | 0 | 34 | 2 | 34 |
| EG005 | 3% Twice a Day | BOL-303242-X dosed in the eye | 0 | 33 | 2 | 33 |
| EG006 | Vehicle | Vehicle of BOL-303242-X dosed in the eye | 0 | 34 | 7 | 34 |
| Visual acuity reduced | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Instillation site abnormal sensation | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Instillation site pruritus | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |