Healthy Subjects
Conditions
Brief summary
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
Detailed description
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.
Interventions
DRUGAC-170 0.24%
DRUGAC-170 Vehicle
Sponsors
ORA, Inc.
Nicox Ophthalmics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 2 years of age * be able to self-administer eye drops or have a parent/legal guardian available for this purpose * if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis) * have ocular health within normal limits
Exclusion criteria
* known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study * be pregnant, nursing, or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of AC 170 0.24% at Visit 1 (Day 1) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
| Tolerability of AC 170 0.24% at Visit 2 (Day 8) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
| Tolerability of AC 170 0.24% at Visit 3 (Day 22) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
| Number of Treatment Related Adverse Events | up to 12 weeks | Adverse events will be measured through study completion |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from six sites in the US.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AC-170 0.24% 1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24% | 343 |
| AC-170 Vehicle 1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle | 173 |
| Total | 516 |
Baseline characteristics
| Characteristic | AC-170 Vehicle | Total | AC-170 0.24% |
|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 18.3 | 32.2 years STANDARD_DEVIATION 17.31 | 32.5 years STANDARD_DEVIATION 16.81 |
| Age, Customized 13-17 years old | 17 participants | 54 participants | 37 participants |
| Age, Customized >/= 18 years old | 129 participants | 388 participants | 259 participants |
| Age, Customized 2-6 years old | 12 participants | 31 participants | 18 participants |
| Age, Customized 2 years old | 8 participants | 14 participants | 6 participants |
| Age, Customized 3 years old | 2 participants | 7 participants | 5 participants |
| Age, Customized 4-12 years old | 17 participants | 53 participants | 36 participants |
| Age, Customized 7-12 years old | 15 participants | 44 participants | 29 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 98 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants | 418 Participants | 285 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 85 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) White | 126 Participants | 396 Participants | 270 Participants |
| Region of Enrollment United States | 173 participants | 516 participants | 343 participants |
| Sex: Female, Male Female | 102 Participants | 299 Participants | 197 Participants |
| Sex: Female, Male Male | 71 Participants | 217 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 343 | 15 / 173 |
| serious Total, serious adverse events | 2 / 343 | 0 / 173 |
Outcome results
Primary
Number of Treatment Related Adverse Events
Adverse events will be measured through study completion
Time frame: up to 12 weeks
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC-170 0.24% | Number of Treatment Related Adverse Events | 27 adverse events |
| AC-170 Vehicle | Number of Treatment Related Adverse Events | 15 adverse events |
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.
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | Upon instillation | 0.87 units on a scale | Standard Deviation 1.435 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 30 seconds post-instillation | 0.64 units on a scale | Standard Deviation 1.181 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 1 minute post-instillation | 0.42 units on a scale | Standard Deviation 1.001 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | Upon instillation | 0.50 units on a scale | Standard Deviation 1.106 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 30 seconds post-instillation | 0.42 units on a scale | Standard Deviation 0.982 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 1 (Day 1) | 1 minute post-instillation | 0.31 units on a scale | Standard Deviation 0.822 |
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.
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 1 minute post-instillation | 0.26 units on a scale | Standard Deviation 0.801 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | Upon instillation | 0.65 units on a scale | Standard Deviation 1.279 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 30 seconds post-instillation | 0.38 units on a scale | Standard Deviation 0.872 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 30 seconds post-instillation | 0.24 units on a scale | Standard Deviation 0.766 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | Upon instillation | 0.19 units on a scale | Standard Deviation 0.665 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 2 (Day 8) | 1 minute post-instillation | 0.21 units on a scale | Standard Deviation 0.65 |
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.
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | Upon instillation | 0.66 units on a scale | Standard Deviation 1.321 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 30 seconds post-instillation | 0.37 units on a scale | Standard Deviation 0.942 |
| AC-170 0.24% | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 1 minute post-instillation | 0.24 units on a scale | Standard Deviation 0.715 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | Upon instillation | 0.43 units on a scale | Standard Deviation 1.036 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 30 seconds post-instillation | 0.25 units on a scale | Standard Deviation 0.725 |
| AC-170 Vehicle | Tolerability of AC 170 0.24% at Visit 3 (Day 22) | 1 minute post-instillation | 0.14 units on a scale | Standard Deviation 0.446 |