Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedApril 12, 2012
April 1, 2011
10 months
April 21, 2011
April 11, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline of the score of tearing
Day 28
Change from baseline of the score of itching
Day 28
Change from baseline of the score of conjunctival hyperaemia
Day 28
Secondary Outcomes (2)
Global local tolerance assessment by the Investigator and the patient
Day 7
Global local tolerance assessment by the Investigator and the patient
Day 28
Study Arms (2)
T1210
EXPERIMENTALOlopatadine hydrochloride
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Conjunctivitis allergic conjunctivitis
You may not qualify if:
- Severe ocular allergy
- Vernal keratoconjunctivitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pierre Huguet
Clermont-Ferrand, 63000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 28, 2011
Study Start
April 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
April 12, 2012
Record last verified: 2011-04