Back to resultsSafety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Primary Purpose
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution
olopatadine hydrochloride 0.1% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of seasonal allergic conjunctivitis
Exclusion Criteria:
- Ocular infection or history of ocular herpes infection
- History of retinal detachment or diabetic retinopathy
- Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
- Ocular surgery within 8 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
Outcomes
Primary Outcome Measures
Ocular Itching
Secondary Outcome Measures
Hyperemia
Chemosis
Ocular mucous discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01258309
Brief Title
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
Arm Title
2
Arm Type
Active Comparator
Arm Description
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution
Intervention Description
One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
olopatadine hydrochloride 0.1% ophthalmic solution
Other Intervention Name(s)
Patanol®
Intervention Description
One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
Primary Outcome Measure Information:
Title
Ocular Itching
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Hyperemia
Time Frame
Day 21
Title
Chemosis
Time Frame
Day 21
Title
Ocular mucous discharge
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of seasonal allergic conjunctivitis
Exclusion Criteria:
Ocular infection or history of ocular herpes infection
History of retinal detachment or diabetic retinopathy
Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
Ocular surgery within 8 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Bangalore
State/Province
Karnataka
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
We'll reach out to this number within 24 hrs