Back to resultsEfficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AC-150 Combo
AC-150A 0.1%
AC-150B 0.005%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
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.
Sites / Locations
- Ora, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Other
Arm Label
AC-150 Combo
AC-150A 0.1%
AC-150B 0.005%
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01134328
First Posted
May 28, 2010
Last Updated
September 13, 2017
Sponsor
Aciex Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01134328
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aciex Therapeutics, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AC-150 Combo
Arm Type
Experimental
Arm Title
AC-150A 0.1%
Arm Type
Active Comparator
Arm Title
AC-150B 0.005%
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
AC-150 Combo
Intervention Description
1 drop in each eye for up to 14 days
Intervention Type
Drug
Intervention Name(s)
AC-150A 0.1%
Intervention Description
1 drop in each eye once per day for up to 14 days
Intervention Type
Drug
Intervention Name(s)
AC-150B 0.005%
Intervention Description
1 drop in each eye once per day for up to 14 days
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
1 drop in each eye once per day for up to 14 days
Primary Outcome Measure Information:
Title
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
3, 5, 7 minutes post-CAC
Title
Ocular Itching at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
3, 5, 7 minutes post-CAC
Title
Ocular Itching at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
3, 5, 7 minutes post-CAC
Title
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Secondary Outcome Measure Information:
Title
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ciliary Redness at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ciliary Redness at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Episcleral Redness at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Episcleral Redness at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Total Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Total Redness at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Total Redness at 8 Hours Post-Dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Lid Swelling at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Lid Swelling Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Lid Swelling at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tolerability of Study Medication at Visit 2B
Description
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.
Time Frame
upon instillation, 1 minute and 2 minutes post instillation
Title
Tolerability of Study Medication at Visit 3
Description
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.
Time Frame
upon instillation, 1 minute and 2 minutes post instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas P Marsico, MD
Organizational Affiliation
East West Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora, Inc
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
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