NCT01495338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

December 15, 2011

Last Update Submit

September 13, 2017

Conditions

Normal Ocular Health

Outcome Measures

Primary Outcomes (1)

  • Drop Comfort Score

    drop comfort on 0-10 scale

    during 3 minute period

Study Arms (4)

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

AC-170 0.17%DRUG

1 drop in one eye at one timepoint

AC-170 0.17%
AC-170 0.24% (Formulation 1)DRUG

1 drop in one eye at one timepoint

AC-170 0.24% (Formulation 1)
AC-170 0.24% (Formulation 2)DRUG

1 drop in one eye at one timepoint

AC-170 0.24% (Formulation 2)
Olopatadine hydrochloride 0.2%/Tears Naturale IIDRUG

1 drop in one eye at one timepoint

Olopatadine hydrochloride 0.2%/Tears Naturale II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Interventions

CetirizineOlopatadine HydrochlorideLubricant Eye Drops

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 20, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)