Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

NCT01134328 | Completed Phase 2 Results

• 1 other identifier: 10-100-0005
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (6)

• 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

• 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 8 Hours Post-dose at Visit 4A

  A treatment efficacy CAC was performed 8 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

• 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

• 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 8 Hours Post-dose at Visit 4A

  A treatment efficacy CAC was performed 8 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

Secondary Outcomes (17)

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

  7, 15, 20 minutes post-CAC

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

  7, 15, 20 minutes post-CAC

• Ciliary Redness at 8 Hours Post-dose at Visit 4A

  7, 15, 20 minutes post-CAC

• Episcleral 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

Study Arms (4)

AC-150 Combo

EXPERIMENTAL

Drug: AC-150 Combo

AC-150A 0.1%

ACTIVE COMPARATOR

Drug: AC-150A 0.1%

AC-150B 0.005%

ACTIVE COMPARATOR

Drug: AC-150B 0.005%

Vehicle

OTHER

Drug: Vehicle

Interventions

AC-150 Combo DRUG

1 drop in each eye for up to 14 days

AC-150 Combo

AC-150A 0.1% DRUG

1 drop in each eye once per day for up to 14 days

AC-150A 0.1%

AC-150B 0.005% DRUG

1 drop in each eye once per day for up to 14 days

AC-150B 0.005%

Vehicle DRUG

1 drop in each eye once per day for up to 14 days

Vehicle

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 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

• Nicholas P Marsico, MD

  East West Eye Institute

  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: May 28, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-09

Locations

US (1)