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Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Thea Identifier:
First received: April 21, 2011
Last updated: April 11, 2012
Last verified: April 2011
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.

Condition Intervention Phase
Seasonal Allergic Conjunctivitis Drug: T1210 Drug: Olopatadine hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Change from baseline of the score of tearing [ Time Frame: Day 28 ]
  • Change from baseline of the score of itching [ Time Frame: Day 28 ]
  • Change from baseline of the score of conjunctival hyperaemia [ Time Frame: Day 28 ]

Secondary Outcome Measures:
  • Global local tolerance assessment by the Investigator and the patient [ Time Frame: Day 7 ]
  • Global local tolerance assessment by the Investigator and the patient [ Time Frame: Day 28 ]

Estimated Enrollment: 60
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T1210 Drug: T1210
2 drops T1210 once a day
Active Comparator: Olopatadine hydrochloride Drug: Olopatadine hydrochloride
2 drops once a day Olopatadine


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

  • Severe ocular allergy
  • Vernal keratoconjunctivitis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01344083

Pierre Huguet
Clermont ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

Responsible Party: Laboratoires Thea Identifier: NCT01344083     History of Changes
Other Study ID Numbers: LT1210-PII-04/10
Study First Received: April 21, 2011
Last Updated: April 11, 2012

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017