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The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% 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 0.24% | Experimental |
| |
| AC-170 0% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-170 0.24% | Drug | 1 drop in each eye at 2 separate times during a 14 day period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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. | 7, 15, 20 minutes post-CAC |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness at Duration of Action (8 Hours + 30 Minutes) | A treatment efficacy CAC was performed 8 hours + 30 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn DeCastro, MD | Andover Eye Associates | Principal Investigator |
| Edward Meier, MD | Eye Care Associates of Greater Cincinnati | Principal Investigator |
| Stacey Ackerman, MD | Philadelphia Eye Associates | Principal Investigator |
| Eugene Protzko, MD | Seidenberg Protzko Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
There were 100 subjects enrolled, 4 subjects discontinued, and 96 subjects completed the study. Participant flow and baseline characteristics are presented for the 100 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.
Subjects were recruited from one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period |
| FG001 | AC-170 0% | AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AC-170 0.24% | AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period |
| BG001 | AC-170 0% | AC-170 0%: 1 drop in each eye at 2 separate times during a 14 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
|
Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. 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 0.24% | AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | 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% |
| Drug |
1 drop in each eye at 2 separate times during a 14 day period |
|
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| Chemosis at Onset of Action (15 Minutes) | 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
| 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 Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | 7, 15, 20 minutes post-CAC |
| Tolerability of Study Medication at Visit 3A | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | upon instillation, 1 minute and 2 minutes post instillation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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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 |
|
|
|
| Primary | Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
|
|
|
| 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 |
|
|
|
| Secondary | Ciliary Redness at Duration of Action (8 Hours + 30 Minutes) | A treatment efficacy CAC was performed 8 hours + 30 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) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
|
|
|
| Secondary | Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 | 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 |
|
|
|
| Secondary | Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
|
|
|
| Secondary | Chemosis at Onset of Action (15 Minutes) | 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 |
|
|
|
| Secondary | Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 |
|
|
|
| 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 |
|
|
|
| Secondary | Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 | 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 | 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 | 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 | 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 Duration of Action (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 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 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 (8 Hours + 30 Minutes Post-dose) | A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Number | %participants with at least 1 nasal symp | 7, 15, 20 minutes post-CAC |
|
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| Secondary | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | Intent to Treat (ITT) | Posted | Number | %participants with at least 1 nasal symp | 7, 15, 20 minutes post-CAC |
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| Secondary | Tolerability of Study Medication at Visit 3A | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | upon instillation, 1 minute and 2 minutes post instillation |
|
|
|
| 0 |
| 50 |
| 5 |
| 50 |
| EG001 | AC-170 0% | AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period | 0 | 50 | 5 | 50 |
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Punctate Keratitis | Eye disorders | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngeal Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| 7 minutes post-CAC |
|
| 20 minutes post-CAC |
|
| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
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| 20 minutes post-CAC |
|
| 2 minutes post-instillation |
|