A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%

Aciex Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AC 170 0.24%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173249

14-100-0007

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

AC 170 0.24%

Experimental group

Treatment:

Drug: AC 170 0.24%