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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 27, 2014