A Comparison of the Safety and Comfort of AC-170 | NCT01495338

Studies
A Comparison of the Safety and Comfort of AC-170

NCT01495338

Sponsor

Aciex Therapeutics, Inc.

Status

Completed

Last Update Posted

Sep 14, 2017Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Normal Ocular Health

Interventions

AC-170 0.17%
AC-170 0.24% (Formulation 1)
AC-170 0.24% (Formulation 2)
Olopatadine hydrochloride 0.2%/Tears Naturale II

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 15, 2011

First Submission Date that Met QC Criteria

Dec 16, 2011

First Posted Date

Dec 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2017

Last Update Posted Date

Sep 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
AC-170 0.17%	Experimental	Drug: AC-170 0.17%
AC-170 0.24% (Formulation 1)	Experimental	Drug: AC-170 0.24% (Formulation 1)
AC-170 0.24% (Formulation 2)	Experimental	Drug: AC-170 0.24% (Formulation 2)
Olopatadine hydrochloride 0.2%/Tears Naturale II	Placebo Comparator	Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AC-170 0.17%	Drug	1 drop in one eye at one timepoint	AC-170 0.17%

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andover Eye Associates		Andover	Massachusetts	01810	United States

Intervention Browse Module

MeSH Terms

ID	Term
D017332	Cetirizine
D000069605	Olopatadine Hydrochloride
D065346	Lubricant Eye Drops

Ancestor Terms

ID	Term
D006919	Hydroxyzine
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided