A Comparison of the Safety and Comfort of AC-170

This study has been completed.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
First received: December 15, 2011
Last updated: January 9, 2012
Last verified: January 2012

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

Condition Intervention Phase
Normal Ocular Health
Drug: AC-170 0.17%
Drug: AC-170 0.24% (Formulation 1)
Drug: AC-170 0.24% (Formulation 2)
Drug: Olopatadine hydrochloride 0.2%
Drug: Tears Naturale II (vehicle)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Aciex Therapeutics, Inc.:

Primary Outcome Measures:
  • Drop Comfort Score [ Time Frame: during 3 minute period ] [ Designated as safety issue: No ]
    drop comfort on 0-10 scale

Enrollment: 60
Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Olopatadine hydrochloride 0.2% Drug: Olopatadine hydrochloride 0.2%
1 drop in one eye at one timepoint
Placebo Comparator: Tears Naturale II (vehicle) Drug: Tears Naturale II (vehicle)
1 drop in one eye at one timepoint


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01495338

United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Aciex Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01495338     History of Changes
Other Study ID Numbers: 11-100-0013
Study First Received: December 15, 2011
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 31, 2015