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
Verified date | July 2019 |
Source | Southern California College of Optometry |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Moderate to severe allergic subjects (= 2.5 on a 0.0 to 4.0 itching scale AND > grade 2.0 bulbar redness using validated (Efron) scale) - Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB). - Can comply with instillation of study drug - Must be able to comply with the visit schedule and other requirements of the study. Exclusion Criteria: - Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions. - Active inflammation of the cornea, iris, anterior chamber - Active or suspected herpetic eye disease (simplex, vaccinia, varicella) - Active or suspected mycobacterial or acanthamoeba infection - Active for suspected fungal disorders of the eye - Persistent and significant dry eye syndrome - Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components - Pregnancy or breast-feeding - Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study. - Participation in any other study within 30 days of this study. |
Country | Name | City | State |
---|---|---|---|
United States | Eye Car Center, Southern California college of Optometry | Fullerton | California |
United States | Eye Care Center, Southern Caalifornia College of Optometry | Fullerton | California |
Lead Sponsor | Collaborator |
---|---|
Southern California College of Optometry |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Ocular Itching at 14 Days | Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point. | Change from Baseline in Ocular Itching at 14 Days |
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 |
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 |
NCT00534794 -
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
|
Phase 4 | |
Completed |
NCT00586664 -
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
|
Phase 3 |