Clinical trial NCT01134328: Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
Official title: A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 83
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Positive bilateral conjunctival allergen challenge(CAC) reaction

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Ocular Itching at Onset of Action (15 Minutes Post-dose)
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Duration of Action (16 Hours Post-dose)
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at 8 Hours Post-dose at Visit 4A
timeFrame: 3, 5, 7 minutes post-CAC
measure: Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Conjunctival Redness at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Conjunctival Redness at 8 Hours Post-dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
Secondary outcomes:
measure: Ciliary Redness at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ciliary Redness at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ciliary Redness at 8 Hours Post-dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
measure: Episcleral Redness at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Episcleral Redness at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Episcleral Redness at 8 Hours Post-dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
measure: Total Redness at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Total Redness at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Total Redness at 8 Hours Post-Dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
measure: Lid Swelling at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Lid Swelling Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Lid Swelling at 8 Hours Post-dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
timeFrame: 7, 15, 20 minutes post-CAC
measure: Tolerability of Study Medication at Visit 2B
timeFrame: upon instillation, 1 minute and 2 minutes post instillation
measure: Tolerability of Study Medication at Visit 3
timeFrame: upon instillation, 1 minute and 2 minutes post instillation
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail L Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East West Eye Institute
name: Nicholas P Marsico, MD
role: PRINCIPAL_INVESTIGATOR
References: