Atopic Disease (Including Allergic Conjunctivitis)
Conditions
Brief summary
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).
Interventions
DRUGDrug: AC-170 0.24%
DRUGAC-170 0%
Sponsors
Aciex Therapeutics, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AC 170 0.024% Compared to Its Vehicle | Up to 12 Weeks | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from four sites in the US.
Pre-assignment details
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%.
Participants by arm
| Arm | Count |
|---|---|
| AC-170 0.24% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24% | 341 |
| AC-170 0% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0% | 171 |
| Total | 512 |
Baseline characteristics
| Characteristic | AC-170 0% | Total | AC-170 0.24% |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 19.56 | 35.4 years STANDARD_DEVIATION 19.42 | 34.9 years STANDARD_DEVIATION 19.36 |
| Age, Customized 13-17 years old | 16 participants | 50 participants | 34 participants |
| Age, Customized >/= 18 years old | 130 participants | 389 participants | 259 participants |
| Age, Customized 2-6 years old | 13 participants | 33 participants | 20 participants |
| Age, Customized 7-12 years old | 12 participants | 40 participants | 28 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 31 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 481 Participants | 321 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 37 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 18 Participants | 14 Participants |
| Race (NIH/OMB) White | 149 Participants | 447 Participants | 298 Participants |
| Region of Enrollment United States | 171 participants | 512 participants | 341 participants |
| Sex: Female, Male Female | 114 Participants | 309 Participants | 195 Participants |
| Sex: Female, Male Male | 57 Participants | 203 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 | 65 / 341 | 39 / 171 |
| serious Total, serious adverse events | 1 / 341 | 1 / 171 |
Outcome results
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.
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% Compared to Its Vehicle at Visit 1 (Day 1) | Upon instillation | 0.9 units on a scale | Standard Deviation 1.36 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | 30 seconds post-instillation | 0.7 units on a scale | Standard Deviation 1.25 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | 1 minute post-instillation | 0.6 units on a scale | Standard Deviation 1.22 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | Upon instillation | 0.5 units on a scale | Standard Deviation 1.02 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | 30 seconds post-instillation | 0.3 units on a scale | Standard Deviation 0.82 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | 1 minute post-instillation | 0.3 units on a scale | Standard Deviation 0.75 |
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.
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% Compared to Its Vehicle at Visit 2 (Day 8) | Upon instillation | 0.8 units on a scale | Standard Deviation 1.24 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | 30 seconds post-instillation | 0.5 units on a scale | Standard Deviation 1.02 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | 1 minute post-instillation | 0.4 units on a scale | Standard Deviation 0.9 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | Upon instillation | 0.3 units on a scale | Standard Deviation 0.8 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | 30 seconds post-instillation | 0.3 units on a scale | Standard Deviation 0.74 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | 1 minute post-instillation | 0.2 units on a scale | Standard Deviation 0.63 |
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.
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% Compared to Its Vehicle at Visit 3 (Day 22) | Upon instillation | 0.6 units on a scale | Standard Deviation 1.13 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | 30 seconds post-instillation | 0.4 units on a scale | Standard Deviation 0.83 |
| AC-170 0.24% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | 1 minute post-instillation | 0.3 units on a scale | Standard Deviation 0.8 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | Upon instillation | 0.2 units on a scale | Standard Deviation 0.66 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | 30 seconds post-instillation | 0.2 units on a scale | Standard Deviation 0.51 |
| AC-170 0% | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | 1 minute post-instillation | 0.1 units on a scale | Standard Deviation 0.47 |
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).
Time frame: Up to 12 Weeks
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC-170 0.24% | Safety of AC 170 0.024% Compared to Its Vehicle | 70 adverse events |
| AC-170 0% | Safety of AC 170 0.024% Compared to Its Vehicle | 40 adverse events |