A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-08-31

Brief Summary

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This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

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Detailed Description

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Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AC-170 0.24%

1 drop in each eye 3 times daily for up to 6 weeks

Group Type EXPERIMENTAL

AC-170 0.24%

Intervention Type DRUG

AC-170 Vehicle

1 drop in each eye 3 times daily for up to 6 weeks

Group Type PLACEBO_COMPARATOR

AC-170 Vehicle

Intervention Type DRUG

Interventions

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AC-170 0.24%

Intervention Type DRUG

AC-170 Vehicle

Intervention Type DRUG

Eligibility Criteria

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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
* be pregnant, nursing, or planning a pregnancy

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No