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

• ClinicalTrials.gov Identifier: NCT01134328
• Recruitment Status: Completed
• First Posted: June 2, 2010
• Results First Posted: September 14, 2017
• Last Update Posted: September 14, 2017
• Sponsor: Aciex Therapeutics, Inc.
• Information provided by (Responsible Party): Aciex Therapeutics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: AC-150 Combo; Drug: AC-150A 0.1%; Drug: AC-150B 0.005%; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: May 2010
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: AC-150 Combo	Drug: AC-150 Combo; 1 drop in each eye for up to 14 days
Active Comparator: AC-150A 0.1%	Drug: AC-150A 0.1%; 1 drop in each eye once per day for up to 14 days
Active Comparator: AC-150B 0.005%	Drug: AC-150B 0.005%; 1 drop in each eye once per day for up to 14 days
Vehicle	Drug: Vehicle; 1 drop in each eye once per day for up to 14 days

Outcome Measures

Primary Outcome Measures :

1. Ocular Itching at Onset of Action (15 Minutes Post-dose) [ Time Frame: 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.
2. Ocular Itching at Duration of Action (16 Hours Post-dose) [ Time Frame: 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.
3. Ocular Itching at 8 Hours Post-dose at Visit 4A [ Time Frame: 3, 5, 7 minutes post-CAC ]
   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.
4. Conjunctival Redness at Onset of Action (15 Minutes Post-dose) [ Time Frame: 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.
5. Conjunctival Redness at Duration of Action (16 Hours Post-dose) [ Time Frame: 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.
6. Conjunctival Redness at 8 Hours Post-dose at Visit 4A [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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 :

1. Ciliary Redness at Onset of Action (15 Minutes Post-dose) [ Time Frame: 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.
2. Ciliary Redness at Duration of Action (16 Hours Post-dose) [ Time Frame: 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.
3. Ciliary Redness at 8 Hours Post-dose at Visit 4A [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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.
4. Episcleral Redness at Onset of Action (15 Minutes Post-dose) [ Time Frame: 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.
5. Episcleral Redness at Duration of Action (16 Hours Post-dose) [ Time Frame: 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.
6. Episcleral Redness at 8 Hours Post-dose at Visit 4A [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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. Total Redness at Onset of Action (15 Minutes Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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.
8. Total Redness at Duration of Action (16 Hours Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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.
9. Total Redness at 8 Hours Post-Dose at Visit 4A [ Time Frame: 7, 15, 20 minutes post-CAC ]
   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.
10. Lid Swelling at Onset of Action (15 Minutes Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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.
11. Lid Swelling Duration of Action (16 Hours Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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.
12. Lid Swelling at 8 Hours Post-dose at Visit 4A [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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.
13. Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) [ Time Frame: 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.
14. Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) [ Time Frame: 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.
15. Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A [ Time Frame: 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.
16. Tolerability of Study Medication at Visit 2B [ Time Frame: 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.
17. Tolerability of Study Medication at Visit 3 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Ora, Inc

Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Aciex Therapeutics, Inc.

Investigators

• Principal Investigator: Gail L Torkildsen, MD; Andover Eye Associates
• Principal Investigator: Nicholas P Marsico, MD; East West Eye Institute

More Information

• Responsible Party: Aciex Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01134328
• Other Study ID Numbers: 10-100-0005
• First Posted: June 2, 2010
• Results First Posted: September 14, 2017
• Last Update Posted: September 14, 2017
• Last Verified: September 2017

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases