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The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-4943A | Experimental | AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| PATADAY | Active Comparator | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| PATANOL | Active Comparator | Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| Vehicle | Placebo Comparator | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-4943A ophthalmic solution | Drug |
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| Olopatadine hydrochloride ophthalmic solution, 0.2% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Itching at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. | Day 14 (3, 5, and 7 minutes post-CAC) |
| Mean Ocular Itching at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. | Day 1 (3, 5, and 7 minutes post-CAC) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Conjunctival Redness at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. | Day 14 (7, 15, and 20 minutes post-CAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhijit Narvekar, MS, MBBS | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27466061 | Derived | Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26. | |
| 26266427 | Derived | McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562. |
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Of the 902 enrolled, 557 participants discontinued prior to randomization due to screen failure (390), adverse event (12), lost to follow-up (26), protocol violation (2), withdrawal by patient (85), and other (42). This reporting group includes all randomized participants (345).
Participants were recruited from 6 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AL-4943A | AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| FG001 | PATADAY | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Olopatadine hydrochloride ophthalmic solution, 0.1% | Drug |
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| AL-4943A ophthalmic solution vehicle | Drug |
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| Mean Conjunctival Redness at 24 Hours Duration of Action |
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Day 1 (7, 15, and 20 minutes post-CAC) |
| Mean Total Redness at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. | Day 14 (7, 15, and 20 minutes post-CAC) |
| Mean Total Redness at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. | Day 1 (7, 15, and 20 minutes post-CAC) |
| Proportion of Ocular Itching Responders at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. | Day 14 |
| Proportion of Itch Responders at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. | Day 1 |
| FG002 | PATANOL | Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| FG003 | Vehicle | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| NOT COMPLETED |
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This analysis population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | AL-4943A | AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| BG001 | PATADAY | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| BG002 | PATANOL | Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| BG003 | Vehicle | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Ocular Itching at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 14 (3, 5, and 7 minutes post-CAC) |
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| Primary | Mean Ocular Itching at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 (3, 5, and 7 minutes post-CAC) |
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| Secondary | Mean Conjunctival Redness at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 14 (7, 15, and 20 minutes post-CAC) |
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| Secondary | Mean Conjunctival Redness at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 (7, 15, and 20 minutes post-CAC) |
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| Secondary | Mean Total Redness at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 14 (7, 15, and 20 minutes post-CAC) |
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| Secondary | Mean Total Redness at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 (7, 15, and 20 minutes post-CAC) |
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| Secondary | Proportion of Ocular Itching Responders at Onset of Action | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis. | Posted | Number | percentage of participants | Day 14 |
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| Secondary | Proportion of Itch Responders at 24 Hours Duration of Action | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis. | Posted | Number | percentage of participants | Day 1 |
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Adverse events (AEs) were collected for the duration of the study (6 months). This analysis population includes all participants who were exposed to investigational product for 1-2 instillation(s).
An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained as solicited comments from the study patients and as observations by the study Investigator.
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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 | AL-4943A | AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 0 | 98 | 0 | 98 | ||
| EG001 | PATADAY | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 0 | 99 | 0 | 99 | ||
| EG002 | PATANOL | Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 0 | 99 | 0 | 99 | ||
| EG003 | Vehicle | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 0 | 49 | 0 | 49 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Wheeler, Unit Head, Pharma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| ≥65 - <75 Years |
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| ≥75 - <85 Years |
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| Male |
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| 5 minutes post-CAC |
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| 7 minutes post-CAC |
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AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| Vehicle |
AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| OG003 | Vehicle | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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| OG003 | Vehicle | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
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