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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134328
• Other study ID #: 10-100-0005
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2010
• Last updated: September 13, 2017
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: September 2017
• Source: Aciex Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• AC-150 Combo
1 drop in each eye for up to 14 days
• AC-150A 0.1%
1 drop in each eye once per day for up to 14 days
• AC-150B 0.005%
1 drop in each eye once per day for up to 14 days
• Vehicle
1 drop in each eye once per day for up to 14 days

Locations

Country	Name	City	State
United States	Ora, Inc	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aciex Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Ciliary Redness at Onset of Action (15 Minutes Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Ciliary Redness at Duration of Action (16 Hours Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Ciliary Redness at 8 Hours Post-dose at Visit 4A	A treatment efficacy CAC was performed 8 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.	7, 15, 20 minutes post-CAC
Secondary	Episcleral Redness at Onset of Action (15 Minutes Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Episcleral Redness at Duration of Action (16 Hours Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Episcleral Redness at 8 Hours Post-dose at Visit 4A	A treatment efficacy CAC was performed 8 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.	7, 15, 20 minutes post-CAC
Secondary	Total Redness at Onset of Action (15 Minutes Post-dose)	A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.	7, 15, 20 minutes post-CAC
Secondary	Total Redness at Duration of Action (16 Hours Post-dose)	A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.	7, 15, 20 minutes post-CAC
Secondary	Total Redness at 8 Hours Post-Dose at Visit 4A	A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.	7, 15, 20 minutes post-CAC
Secondary	Lid Swelling at Onset of Action (15 Minutes Post-dose)	A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Secondary	Lid Swelling Duration of Action (16 Hours Post-dose)	A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Secondary	Lid Swelling at 8 Hours Post-dose at Visit 4A	A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Secondary	Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)	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.	7, 15, 20 minutes post-CAC
Secondary	Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A	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.	7, 15, 20 minutes post-CAC
Secondary	Tolerability of Study Medication at Visit 2B	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.	upon instillation, 1 minute and 2 minutes post instillation
Secondary	Tolerability of Study Medication at Visit 3	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.	upon instillation, 1 minute and 2 minutes post instillation