NCT02173249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

June 13, 2014

Last Update Submit

September 13, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Cmax values of AC 170 0.24%

    Plasma samples will be drawn at specified time points and then analyzed to determine Cmax values of AC 170 0.24% in the plasma

    1 week

  • Tmax values of AC 170 0.24%

    Plasma samples will be drawn at specified time points and then analyzed to determine Tmax values of AC 170 0.24% in the plasma

    1 week

  • AUC values of AC 170 0324%

    Plasma samples will be drawn at specified time points and then analyzed to determine AUC values of AC 170 0.24% in the plasma

    1 week

  • T 1/2 values of AC 170 0.24%

    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

    1 week

Study Arms (1)

AC 170 0.24%

EXPERIMENTAL
Drug: AC 170 0.24%

Interventions

AC 170 0.24%DRUG

1 drop in each eye 2 times daily for 1 week

AC 170 0.24%

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)