Back to resultsAlrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Primary Purpose
Seasonal Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Loteprednol etabonate 0.2%
Olopatadine 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Conjunctivitis focused on measuring ocular allergy
Eligibility Criteria
Inclusion Criteria:
- Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Exclusion Criteria:
- Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
- Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
- Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
- Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Sites / Locations
- Bausch & Lomb Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alrex
Patanol
Arm Description
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Ophthalmic solution containing olopatadine, 0.1%
Outcomes
Primary Outcome Measures
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Secondary Outcome Measures
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Full Information
NCT ID
NCT01435460
First Posted
September 14, 2011
Last Updated
February 17, 2012
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01435460
Brief Title
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Official Title
A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Conjunctivitis
Keywords
ocular allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alrex
Arm Type
Experimental
Arm Description
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Arm Title
Patanol
Arm Type
Active Comparator
Arm Description
Ophthalmic solution containing olopatadine, 0.1%
Intervention Type
Drug
Intervention Name(s)
Loteprednol etabonate 0.2%
Other Intervention Name(s)
Alrex
Intervention Description
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Olopatadine 0.1%
Other Intervention Name(s)
Patanol
Intervention Description
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
Primary Outcome Measure Information:
Title
Bulbar Conjunctival Injection
Description
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Time Frame
Change from baseline to day 15 (visit 3)
Title
Ocular Itching
Description
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Time Frame
Change from baseline to day 15 (visit 3)
Secondary Outcome Measure Information:
Title
Bulbar Conjunctival Injection
Description
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Time Frame
Change from baseline to day 8 (visit 2)
Title
Ocular Itching
Description
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Time Frame
Change from baseline to day 8 (visit 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Exclusion Criteria:
Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Chu
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Singapore
City
Singapore
ZIP/Postal Code
556741
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
22627057
Citation
Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.
Results Reference
derived
Learn more about this trial
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
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