Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.
Interventions
DRUGAC 170 0.24%
1 drop in each eye 2 times daily for 1 week
Sponsors
Aciex Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* at least 18 and no older than 55 years of age * be able to self-administer eye drops or have a parent/legal guardian available for this purpose * have blood and urine analysis within normal limits * have ocular health within normal limits
Exclusion criteria
* known contraindications or sensitivities to the study medication or its components * have any active systemic or ocular disorder (other than refractive disorder) * have inability to comply with controlled diet * have used prescription or non prescription drugs within washout period and throughout study * have used alcohol or tobacco within the washout period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax values of AC 170 0.24% | 1 week | Plasma samples will be drawn at specified time points and then analyzed to determine Cmax values of AC 170 0.24% in the plasma |
| Tmax values of AC 170 0.24% | 1 week | Plasma samples will be drawn at specified time points and then analyzed to determine Tmax values of AC 170 0.24% in the plasma |
| AUC values of AC 170 0324% | 1 week | Plasma samples will be drawn at specified time points and then analyzed to determine AUC values of AC 170 0.24% in the plasma |
| T 1/2 values of AC 170 0.24% | 1 week | Plasma samples will be drawn at specified time points and then analyzed to determine T 1/2 values of AC 170 0.24% in the plasma |
Countries
United States
Outcome results
None listed