A Comparison of the Safety and Comfort of AC-170

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC-170 0.17%	Drug: AC-170 0.17%; 1 drop in one eye at one timepoint
Experimental: AC-170 0.24% (Formulation 1)	Drug: AC-170 0.24% (Formulation 1); 1 drop in one eye at one timepoint
Experimental: AC-170 0.24% (Formulation 2)	Drug: AC-170 0.24% (Formulation 2); 1 drop in one eye at one timepoint
Placebo Comparator: Olopatadine hydrochloride 0.2%/Tears Naturale II	Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II; 1 drop in one eye at one timepoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop Comfort Score	drop comfort on 0-10 scale	during 3 minute period

Collaborators and Investigators

• Sponsor: Aciex Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine; Olopatadine Hydrochloride
• Other Study ID Numbers: 11-100-0013