NCT01561521

Brief Summary

The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 18, 2013

Status Verified

May 1, 2012

Enrollment Period

1 month

First QC Date

March 21, 2012

Last Update Submit

July 16, 2013

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Ocular Itching at defined time points up to 2 weeks

    Baseline to day 14

  • Ocular Redness at defined time points up to 2 weeks

    Baseline to day 14

Study Arms (3)

AKF-1 0.025%

EXPERIMENTAL
Drug: AKF-1

AKF-1 0.035%

EXPERIMENTAL
Drug: AKF-1

AKF-1 0%

PLACEBO COMPARATOR
Drug: AKF-1

Interventions

AKF-1DRUG

1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period

AKF-1 0.025%

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • positive bilateral conjunctival allergen challenge (CAC) reaction

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 medication during the period indicated prior to the 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

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 18, 2013

Record last verified: 2012-05

Locations

US(1)