Back to resultsComparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
Primary Purpose
Seasonal Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
T1210
Olopatadine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Conjunctivitis allergic conjunctivitis
Exclusion Criteria:
- Severe ocular allergy
- Vernal keratoconjunctivitis
Sites / Locations
- Pierre Huguet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T1210
Olopatadine hydrochloride
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline of the score of tearing
Change from baseline of the score of itching
Change from baseline of the score of conjunctival hyperaemia
Secondary Outcome Measures
Global local tolerance assessment by the Investigator and the patient
Global local tolerance assessment by the Investigator and the patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01344083
Brief Title
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T1210
Arm Type
Experimental
Arm Title
Olopatadine hydrochloride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
T1210
Intervention Description
2 drops T1210 once a day
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride
Intervention Description
2 drops once a day Olopatadine
Primary Outcome Measure Information:
Title
Change from baseline of the score of tearing
Time Frame
Day 28
Title
Change from baseline of the score of itching
Time Frame
Day 28
Title
Change from baseline of the score of conjunctival hyperaemia
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Global local tolerance assessment by the Investigator and the patient
Time Frame
Day 7
Title
Global local tolerance assessment by the Investigator and the patient
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Conjunctivitis allergic conjunctivitis
Exclusion Criteria:
Severe ocular allergy
Vernal keratoconjunctivitis
Facility Information:
Facility Name
Pierre Huguet
City
Clermont ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
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