A Comparison of the Safety and Comfort of AC-170

NCT ID: NCT01495338

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

Detailed Description

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Conditions

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Normal Ocular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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AC-170 0.17%

Group Type EXPERIMENTAL

AC-170 0.17%

Intervention Type DRUG

1 drop in one eye at one timepoint

AC-170 0.24% (Formulation 1)

Group Type EXPERIMENTAL

AC-170 0.24% (Formulation 1)

Intervention Type DRUG

1 drop in one eye at one timepoint

AC-170 0.24% (Formulation 2)

Group Type EXPERIMENTAL

AC-170 0.24% (Formulation 2)

Intervention Type DRUG

1 drop in one eye at one timepoint

Olopatadine hydrochloride 0.2%/Tears Naturale II

Group Type PLACEBO_COMPARATOR

Olopatadine hydrochloride 0.2%/Tears Naturale II

Intervention Type DRUG

1 drop in one eye at one timepoint

Interventions

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AC-170 0.17%

1 drop in one eye at one timepoint

Intervention Type DRUG

AC-170 0.24% (Formulation 1)

1 drop in one eye at one timepoint

Intervention Type DRUG

AC-170 0.24% (Formulation 2)

1 drop in one eye at one timepoint

Intervention Type DRUG

Olopatadine hydrochloride 0.2%/Tears Naturale II

1 drop in one eye at one timepoint

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.

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 or trial parameters.
* Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Minimum Eligible Age

18 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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11-100-0013

Identifier Type: -

Identifier Source: org_study_id

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