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A Comparison of the Safety and Comfort of AC-170

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ClinicalTrials.gov Identifier: NCT01495338
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.

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

Condition or disease Intervention/treatment 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%/Tears Naturale II Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : December 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Drop Comfort Score [ Time Frame: during 3 minute period ]
    drop comfort on 0-10 scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495338


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

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01495338     History of Changes
Other Study ID Numbers: 11-100-0013
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Olopatadine Hydrochloride
Cetirizine
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