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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: AC-170 0.05%; Drug: AC-170 0.1%; Drug: AC-170 0.24%; Drug: AC-170 0%

• Registration Number: NCT01332188
• Lead Sponsor: Aciex Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Disposition First Submitted: 2012-07-10
• Disposition First Submitted QC: 2012-07-10
• Disposition First Posted: 2012-07-19
• Results First Submitted: 2017-06-28
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Results First Posted: 2017-08-30
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-170 0.05%	AC-170 0.05%	-
AC-170 0.1%	AC-170 0.1%	-
AC-170 0.24%	AC-170 0.24%	-
AC-170 0%	AC-170 0%	-

Primary Outcome Measures

Name	Time	Method
Ocular Itching at Duration of Action (24 Hours Post-dose)	3, 5, 7 minutes post-CAC	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.
Ocular Itching at Onset of Action (15 Minutes Post-dose)	3, 5, 7 minutes post-CAC	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.
Conjunctival Redness at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	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.
Conjunctival Redness at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	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.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Ocular Itching at Duration of Action (16 Hours Post-dose)	3, 5, 7 minutes post-CAC	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.

Secondary Outcome Measures

Name	Time	Method
Ciliary Redness at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Ciliary Redness at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Ciliary Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Episcleral Redness at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Episcleral Redness at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Episcleral Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Chemosis at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Chemosis at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Chemosis at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Eyelid Swelling at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Eyelid Swelling at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Tearing at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Tearing at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Tearing at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Rhinorrhea at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Rhinorrhea at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Rhinorrhea at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Nasal Pruritus at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Nasal Pruritus at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Nasal Congestion at Onset of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Nasal Congestion at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Nasal Congestion at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Nasal Composite Score at Duration of Action (16 Hours Post-dose)	7, 15, 20 minutes post-CAC	A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Nasal Composite Score at Duration of Action (24 Hours Post-dose)	7, 15, 20 minutes post-CAC	A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Tolerability of Study Medication at Visit 3A	upon instillation, 1 minute and 2 minutes post instillation	Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome..

Trial Locations

Locations (1)

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States