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The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-170 0.05% | Experimental |
| |
| AC-170 0.1% | Experimental |
| |
| AC-170 0.24% | Experimental |
| |
| AC-170 0% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-170 0.05% | Drug | 1 drop in each eye at 3 separate times during a 21 day period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Conjunctival Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Conjunctival Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Conjunctival Redness at Onset of Action (15 Minutes Post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Ciliary Redness at Duration of Action (24 Hours Post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail L Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora, Inc. | Andover | Massachusetts | 01810 | United States |
101 subjects were enrolled, 7 subjects discontinued, and 94 subjects completed the study. The 101 subjects that met all inclusion criteria and none of the exclusion criteria were randomized to receive AC-170 0.05%, AC-170 0.1%, AC-170 0.24% or AC-170 0%.
Note: All solutions were "early formulations" and not the final to-be-marketed formulation.
Subjects were recruited from one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AC-170 0.05% | AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period |
| FG001 | AC-170 0.1% | AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period |
| FG002 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period |
| FG003 | AC-170 0% | AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AC-170 0.05% | AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period |
| BG001 | AC-170 0.1% | AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period |
| 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 at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
|
Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
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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 | AC-170 0.05% | AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President | Nicox Ophthalmics Inc. | 817-529-9315 | bergamini@nicox.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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| AC-170 0.1% |
| Drug |
1 drop in each eye at 3 separate times during a 21 day period |
|
| AC-170 0.24% | Drug | 1 drop in each eye at 3 separate times during a 21 day period |
|
| AC-170 0% | Drug | 1 drop in each eye at 3 separate times during a 21 day period |
|
A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. |
| 7, 15, 20 minutes post-CAC |
A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. |
| 7, 15, 20 minutes post-CAC |
| Ciliary Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Episcleral Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Episcleral Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Episcleral Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Chemosis at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Chemosis at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Chemosis at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Eyelid Swelling at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Eyelid Swelling at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Tearing at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Tearing at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Tearing at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Rhinorrhea at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Rhinorrhea at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Rhinorrhea at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Congestion at Onset of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Congestion at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Congestion at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Composite Score at Duration of Action (16 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC |
| Nasal Composite Score at Duration of Action (24 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC |
| Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC |
| Tolerability of Study Medication at Visit 3A | Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.. | upon instillation, 1 minute and 2 minutes post instillation |
| BG002 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period |
| BG003 | AC-170 0% | AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period |
| OG003 | AC-170 0% | AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period |
|
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| Primary | Ocular Itching at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
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| Primary | Ocular Itching at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
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| Primary | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Primary | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Primary | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ciliary Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ciliary Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study. | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Episcleral Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Episcleral Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Chemosis at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Chemosis at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Chemosis at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Tearing at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Tearing at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Tearing at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Rhinorrhea at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Rhinorrhea at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Congestion at Onset of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Congestion at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | Intent to Treat (ITT) | Posted | Number | percentage of subjects | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | Intent to Treat (ITT) | Posted | Number | percentage of subjects | 7, 15, 20 minutes post-CAC |
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| Secondary | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | Intent to Treat (ITT) | Posted | Number | percentage of subjects | 7, 15, 20 minutes post-CAC |
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| Secondary | Tolerability of Study Medication at Visit 3A | Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | upon instillation, 1 minute and 2 minutes post instillation |
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| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | AC-170 0.1% | AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period | 0 | 26 | 3 | 26 |
| EG002 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period | 0 | 25 | 4 | 25 |
| EG003 | AC-170 0% | AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period | 0 | 25 | 2 | 25 |
| Visual acuity reducsed | Eye disorders | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | Systematic Assessment |
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| Palatal Oedema | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Not provided
Not provided
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| 5 minutes post-CAC |
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