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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-170 0.24% | Experimental | 1 drop in each eye 3 times daily for up to 6 weeks |
|
| AC-170 Vehicle | Placebo Comparator | 1 drop in each eye 3 times daily for up to 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-170 0.24% | Drug |
| ||
| AC-170 Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
| Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
| Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
| Number of Treatment Related Adverse Events | Adverse events will be measured through study completion | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Protzko, MD | Sedeinberg Protzko Eye Associates | Principal Investigator |
| Ranjan Malhotra, MD | Ophthalmology Associates | Principal Investigator |
| Stacey Ackerman, MD | Philadelphia Eye Associates | Principal Investigator |
| M. Ali Haider, DO | Haider Eye Care | Principal Investigator |
| Robert Rice, MD | R&R Eye Research | Principal Investigator |
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora Clinical Site Network | Andover | Massachusetts | 01810 | United States |
There were 516 subjects enrolled, 23 subjects discontinued, and 493 subjects completed the study. Participant flow and baseline characteristics are presented for the 516 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 Vehicle.
Subjects were recruited from six sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AC-170 0.24% | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24% |
| FG001 | AC-170 Vehicle | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AC-170 0.24% | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24% |
| BG001 | AC-170 Vehicle | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle |
| 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 | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
|
Adverse events were collected for the duration of the study. 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% | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Substance abuse | Psychiatric disorders | Systematic Assessment |
| 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 |
|---|---|
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
|
|
|
| Primary | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 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, 30 Seconds Post-Instillation, 1 minute Post-Instillation |
|
|
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| Primary | Number of Treatment Related Adverse Events | Adverse events will be measured through study completion | Intent to Treat (ITT) | Posted | Number | adverse events | up to 12 weeks |
|
|
|
| 2 |
| 343 |
| 25 |
| 343 |
| EG001 | AC-170 Vehicle | 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle | 0 | 173 | 15 | 173 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Punctate keratitis | Eye disorders | Systematic Assessment |
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| Instillation site pain | General disorders | Systematic Assessment |
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| Instillation site erythema | General disorders | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
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| 1 minute post-instillation |
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| 1 minute post-instillation |
|