NCT01881113

Brief Summary

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

June 17, 2013

Results QC Date

June 26, 2017

Last Update Submit

October 11, 2017

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (4)

  • Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)

    A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    3, 5, 7 minutes post-CAC

  • Ocular Itching at Onset of Action (15 Minutes Post-Dose)

    A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    3, 5, 7 minutes post-CAC

  • Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)

    A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

    7, 15, 20 minutes post-CAC

  • Conjunctival Redness at Onset of Action (15 Minutes Post-Dose)

    A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

    7, 15, 20 minutes post-CAC

Secondary Outcomes (21)

  • Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)

    7, 15, 20 minutes post-CAC

  • Ciliary Redness at Onset of Action (15 Minutes Post-Dose)

    7, 15, 20 minutes post-CAC

  • Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)

    7, 15, 20 minutes post-CAC

  • Episcleral Redness at Onset of Action (15 Minutes Post-Dose)

    7, 15, 20 minutes post-CAC

  • Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose)

    7, 15, 20 minutes post-CAC

  • +16 more secondary outcomes

Study Arms (2)

AC-170 0.24%

EXPERIMENTAL
Drug: AC-170 0.24%

AC-170 0%

PLACEBO COMPARATOR
Drug: AC-170 0%

Interventions

AC-170 0.24%DRUG

1 drop in each eye at 2 separate times during a 14 day period

AC-170 0.24%
AC-170 0%DRUG

1 drop in each eye at 2 separate times during a 14 day period

AC-170 0%

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 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)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President
Organization
Nicox Ophthalmics Inc.
bergamini@nicox.com
817-529-9315

Study Officials

  • Eugene McLaurin, MD

    Total Eye Care, PA

    PRINCIPAL INVESTIGATOR

  • Edward Meier, MD

    Eye Care Associates of Greater Cincinnati

    PRINCIPAL INVESTIGATOR

  • Mark Bergmann, MD

    Eye Care Associates of Greater Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

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

June 17, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 9, 2017

Results First Posted

November 9, 2017

Record last verified: 2017-10

Locations

US(1)