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

NCT ID: NCT02173249

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AC 170 0.24%

Group Type EXPERIMENTAL

AC 170 0.24%

Intervention Type DRUG

1 drop in each eye 2 times daily for 1 week

Interventions

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AC 170 0.24%

1 drop in each eye 2 times daily for 1 week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aciex Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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14-100-0007

Identifier Type: -

Identifier Source: org_study_id

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