A Comparison of the Safety and Comfort of AC-170

Phase 1

Completed

• Conditions: Normal Ocular Health
• Interventions: Drug: AC-170 0.24% (Formulation 2); Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II; Drug: AC-170 0.17%; Drug: AC-170 0.24% (Formulation 1)

• Registration Number: NCT01495338
• Lead Sponsor: Aciex Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-170 0.24% (Formulation 2)	AC-170 0.24% (Formulation 2)	-
Olopatadine hydrochloride 0.2%/Tears Naturale II	Olopatadine hydrochloride 0.2%/Tears Naturale II	-
AC-170 0.17%	AC-170 0.17%	-
AC-170 0.24% (Formulation 1)	AC-170 0.24% (Formulation 1)	-

Primary Outcome Measures

Name	Time	Method
Drop Comfort Score	during 3 minute period	drop comfort on 0-10 scale

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States