Allergic Conjunctivitis Clinical Trial
Official title:
A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis
Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically,
patients manifest symptoms in the spring, summer and fall, when airborne allergens are at
their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust
mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival
hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and
burning.
This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine
besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the
treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years.
The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms
(itching) will be monitored as outcome variables.
Investigator and Study Center:
Judy Tong, OD Eye Care Center Southern California College of Optometry
Test Product, Dose and Mode of Administration:
Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol
etabonate ophthalmic suspension) 0.2% qid ou
Study Title:
A Single-Center, Masked, Randomized Study Comparing Bepreve (bepotastine besilate) 1.5% - H1
Specific Antihistamine vs. Alrex (loteprednol etabonate) 0.2% - Corticosteroid in Subjects
with Moderate to Severe Allergic Conjunctivitis
Primary Objective(s):
The primary objective of this study is to compare the efficacy of Bepreve (bepotastine
besilate) 1.5% ophthalmic solution compared to Alrex (loteprednol etabonate) 0.2% in the
treatment of moderate to severe allergic conjunctivitis in patients over the age of 18 years
of age
Study Design:
Interventional, Randomized, Parallel Arm, Investigator Masked
Study Population:
Subjects over the age of 18 years of age with moderate to severe allergic conjunctivitis.
Duration of Treatment: 14 days
Efficacy Assessments: Itching, Bulbar conjunctival injection, Bulbar conjunctival chemosis
Safety Assessments: N/A
;
| 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 |
NCT01697969 -
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
|
Phase 4 | |
| Completed |
NCT01685242 -
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
|
Phase 3 | |
| 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 |
NCT01754766 -
AGN-229666 for the Treatment of Allergic Conjunctivitis
|
Phase 2 | |
| Completed |
NCT01698814 -
A Six-Week Safety Study of an Investigational Ophthalmic Solution
|
Phase 3 | |
| 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 |
NCT00534794 -
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
|
Phase 4 | |
| Completed |
NCT00569777 -
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
|
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 |