Clinical trial NCT01881113: A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-19
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 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.


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 trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study

Primary outcomes:
measure: Ocular Itching at Duration of Action (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 (8 Hours + 30 Minutes 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 Duration of Action (8 Hours + 30 Minutes 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: Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Percentage of Participants With At Least One Nasal Symptom 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: Total Eye Care, PA
name: Eugene McLaurin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Care Associates of Greater Cincinnati
name: Edward Meier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Care Associates of Greater Cincinnati
name: Mark Bergmann, MD
role: PRINCIPAL_INVESTIGATOR
References: