Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01443442
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2011-09-27
Brief Title:
Bepreve vs Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Sponsor:
Southern California College of Optometry at Marshall B Ketchum University
Organization:
Southern California College of Optometry at Marshall B Ketchum University
Study Overview
Official Title:
A Single-Center Masked Randomized Study Comparing Bepreve Bepotastine Besilate 15 - H1 Specific Antihistamine vs Alrex Loteprednol Etabonate 02 - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 15 ophthalmic solution compared to Alrex loteprednol etabonate 02 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
This is a randomized clinical study to evaluate the efficacy of Bepreve bepotastine besilate 15 ophthalmic solution compared to Alrex loteprednol etabonate 02 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
Detailed Description:
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 15 bid ou vs Alrex loteprednol etabonate ophthalmic suspension 02 qid ou
Study Title
A Single-Center Masked Randomized Study Comparing Bepreve bepotastine besilate 15 - H1 Specific Antihistamine vs Alrex loteprednol etabonate 02 - Corticosteroid in Subjects with Moderate to Severe Allergic Conjunctivitis
Primary Objectives
The primary objective of this study is to compare the efficacy of Bepreve bepotastine besilate 15 ophthalmic solution compared to Alrex loteprednol etabonate 02 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 NA
Judy Tong OD Eye Care Center Southern California College of Optometry
Test Product Dose and Mode of Administration
Bepreve bepotastine besilate ophthalmic solution 15 bid ou vs Alrex loteprednol etabonate ophthalmic suspension 02 qid ou
Study Title
A Single-Center Masked Randomized Study Comparing Bepreve bepotastine besilate 15 - H1 Specific Antihistamine vs Alrex loteprednol etabonate 02 - Corticosteroid in Subjects with Moderate to Severe Allergic Conjunctivitis
Primary Objectives
The primary objective of this study is to compare the efficacy of Bepreve bepotastine besilate 15 ophthalmic solution compared to Alrex loteprednol etabonate 02 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 NA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None