A Comparison of the Safety and Comfort of AC-170

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01495338
First received: December 15, 2011
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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

  Eligibility

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

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

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

ClinicalTrials.gov processed this record on April 14, 2014