Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model

NCT01332188 | Completed Phase 2 Results

• 1 other identifier: 11-100-0004
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (6)

• Ocular Itching at Duration of Action (16 Hours Post-dose)

  A treatment efficacy CAC was performed 16 hours 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 Duration of Action (24 Hours Post-dose)

  A treatment efficacy CAC was performed 24 hours 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 (16 Hours Post-dose)

  A treatment efficacy CAC was performed 16 hours 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 Duration of Action (24 Hours Post-dose)

  A treatment efficacy CAC was performed 24 hours 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 (31)

• Ciliary Redness at Duration of Action (16 Hours Post-dose)

  7, 15, 20 minutes post-CAC

• Ciliary Redness at Duration of Action (24 Hours 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 (16 Hours Post-dose)

  7, 15, 20 minutes post-CAC

• Episcleral Redness at Duration of Action (24 Hours Post-dose)

  7, 15, 20 minutes post-CAC

Study Arms (4)

AC-170 0.05%

EXPERIMENTAL

Drug: AC-170 0.05%

AC-170 0.1%

EXPERIMENTAL

Drug: AC-170 0.1%

AC-170 0.24%

EXPERIMENTAL

Drug: AC-170 0.24%

AC-170 0%

PLACEBO COMPARATOR

Drug: AC-170 0%

Interventions

AC-170 0.05% DRUG

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0.05%

AC-170 0.1% DRUG

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0.1%

AC-170 0.24% DRUG

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0.24%

AC-170 0% DRUG

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0%

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 medications during the period indicated prior to the study enrollment or during the study.

Sponsors & Collaborators

• Aciex Therapeutics, Inc.: lead

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune 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

• Gail L Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (1)