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This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASTACAFT® (alcaftadine 0.25%) | Active Comparator | One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
|
| Pataday™ (olopatadine 0.2%) | Active Comparator | One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
|
| Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) | Placebo Comparator | One drop of placebo instilled in each eye at Day 0 and Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcaftadine 0.25% ophthalmic solution | Drug | One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. | Day 0 Hour 16 |
| Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. | Day 14 Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia | Pennsylvania | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25260889 | Derived | McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LASTACAFT® (Alcaftadine 0.25%) | One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
| FG001 | Pataday™ (Olopatadine 0.2%) | One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
| FG002 | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | One drop of placebo instilled in each eye at Day 0 and Day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LASTACAFT® (Alcaftadine 0.25%) | One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
| BG001 | Pataday™ (Olopatadine 0.2%) | One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0 Hour 16 |
|
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The Safety Population was defined as all randomized subjects who received at least one dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).
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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 | LASTACAFT® (Alcaftadine 0.25%) | One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.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 |
|---|---|
| C557708 | alcaftadine |
| D009883 | Ophthalmic Solutions |
| D000069605 | Olopatadine Hydrochloride |
| D003911 | Dextrans |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| olopatadine 0.2% ophthalmic solution | Drug | One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
|
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| dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% | Drug | One drop of placebo instilled in each eye at Day 0 and Day 14. |
|
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| Day 14 Hour 24 |
| Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness. | Day 14 Hour 24 |
| Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness. | Day 14 Hour 24 |
| Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis. | Day 14 Hour 24 |
| Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling. | Day 14 Hour 24 |
| Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing. | Day 14 Hour 24 |
| BG002 | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | One drop of placebo instilled in each eye at Day 0 and Day 14. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Pataday™ (Olopatadine 0.2%) |
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. |
| OG002 | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | One drop of placebo instilled in each eye at Day 0 and Day 14. |
|
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| Secondary | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Secondary | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Secondary | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Secondary | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Secondary | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Secondary | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| Primary | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. | Intent-to-Treat: All randomized subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14 Hour 24 |
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| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Pataday™ (Olopatadine 0.2%) | One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. | 0 | 42 | 0 | 42 |
| EG002 | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | One drop of placebo instilled in each eye at Day 0 and Day 14. | 0 | 41 | 0 | 41 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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