Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-170 0.24% | Experimental |
| |
| AC-170 0% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: AC-170 0.24% | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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% Compared to Its Vehicle at Visit 2 (Day 8) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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% Compared to Its Vehicle at Visit 3 (Day 22) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AC 170 0.024% Compared to Its Vehicle | Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients). | Up to 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stacey L Ackerman, MD | Philadelphia Eye Associates | Principal Investigator |
| Dawn K De Castro, MD | Andover Eye Associates | Principal Investigator |
| Edward J Meier, MD | Apex Eye | Principal Investigator |
| Eugene E Protzko, MD | Seidenberg Protzko Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora, Inc. | Andover | Massachusetts | 01810 | United States |
There were 512 subjects enrolled, 24 subjects discontinued, and 488 subjects completed the study. Participant flow and baseline characteristics are presented for the 512 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 four sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AC-170 0.24% | 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24% |
| FG001 | AC-170 0% | 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AC-170 0.24% | 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24% |
| BG001 | AC-170 0% | 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0% |
| 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% Compared to Its Vehicle at Visit 1 (Day 1) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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.
Not provided
| 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 2 times daily for up to 6 weeks AC-170 0.24% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President | Nicox Ophthalmics Inc. | 817-529-9315 | bergamini@nicox.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| AC-170 0% |
| Drug |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| 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 |
|
|
|
| Primary | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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% Compared to Its Vehicle at Visit 3 (Day 22) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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 |
|
|
|
| Secondary | Safety of AC 170 0.024% Compared to Its Vehicle | Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients). | Intent to Treat (ITT) | Posted | Number | adverse events | Up to 12 Weeks |
|
|
|
| 1 |
| 341 |
| 65 |
| 341 |
| EG001 | AC-170 0% | 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0% | 1 | 171 | 39 | 171 |
| Anaphylactic shock | Immune system disorders | Systematic Assessment |
|
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
|
| Vision Blurred | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
|
| Eye discharge | Eye disorders | Systematic Assessment |
|
| Instillation Site Pain | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| 1 minute post-instillation |
|
| 1 minute post-instillation |
|