Clinical trial NCT01332188: Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model
Official title: A Single Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy of Three Different Concentrations of Cetirizine (0.05%, 0.1%, and 0.24%) Ophthalmic Solution Versus Vehicle in the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model (CAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 101
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 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.


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 the study enrollment or during the study.

Primary outcomes:
measure: Ocular Itching at Duration of Action (16 Hours Post-dose)
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Duration of Action (24 Hours Post-dose)
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Onset of Action (15 Minutes Post-dose)
timeFrame: 3, 5, 7 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 Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
Secondary outcomes:
measure: Ciliary Redness at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ciliary Redness at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ciliary 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 Duration of Action (24 Hours Post-dose)
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: Chemosis at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Chemosis at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Chemosis at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Eyelid Swelling at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Eyelid Swelling at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Tearing at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Tearing at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Tearing at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Rhinorrhea at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Rhinorrhea at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Rhinorrhea at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Pruritus at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Pruritus at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal 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 Duration of Action (24 Hours Post-dose)
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: Nasal Congestion at Onset of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Congestion at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Congestion at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Composite Score at Duration of Action (16 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Composite Score at Duration of Action (24 Hours Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Tolerability of Study Medication at Visit 3A
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
References: