Allergic Conjunctivitis Clinical Trial
Official title:
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
| Verified date | October 2017 |
| Source | Aciex Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| 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 medication during the period indicated prior to the enrollment or during the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ora, Inc. | Andover | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Aciex Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour 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 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 | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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 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 | |
| Secondary | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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 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 | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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 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 | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Chemosis at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Tearing at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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 Pruritis 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 | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 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. | 7, 15, 20 minutes post-CAC | |
| Secondary | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | |
| Secondary | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | |
| Secondary | Tolerability of Study Medication at Visit 3A | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | upon instillation, 1 minute and 2 minutes post instillation |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03660878 -
A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
|
Phase 1/Phase 2 | |
| Completed |
NCT03682965 -
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
|
Phase 2 | |
| Completed |
NCT01685242 -
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
|
Phase 3 | |
| Completed |
NCT01697969 -
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
|
Phase 4 | |
| Completed |
NCT01439815 -
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
|
Phase 4 | |
| Completed |
NCT01294969 -
Patient Perception Study for AL-4943A
|
Phase 4 | |
| Completed |
NCT01471184 -
The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo
|
Phase 1 | |
| Completed |
NCT00609128 -
Effect of Olopatadine on Allergic Tear Mediators
|
N/A | |
| Recruiting |
NCT05969236 -
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
|
Phase 1 | |
| Active, not recruiting |
NCT04619017 -
Airway Immune Response to Allergens (Use Lay Language Here)
|
Phase 1 | |
| Not yet recruiting |
NCT01012752 -
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
|
Phase 3 | |
| Completed |
NCT01698814 -
A Six-Week Safety Study of an Investigational Ophthalmic Solution
|
Phase 3 | |
| Completed |
NCT01754766 -
AGN-229666 for the Treatment of Allergic Conjunctivitis
|
Phase 2 | |
| Completed |
NCT01443442 -
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
|
Phase 4 | |
| Completed |
NCT01203540 -
Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients
|
Phase 4 | |
| Completed |
NCT00987272 -
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
|
Phase 3 | |
| Completed |
NCT00769886 -
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
|
Phase 3 | |
| Completed |
NCT00586625 -
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
|
Phase 3 | |
| Completed |
NCT00586664 -
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
|
Phase 3 | |
| Completed |
NCT00534794 -
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
|
Phase 4 |