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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344083
First Posted: April 28, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

  • Severe ocular allergy
  • Vernal keratoconjunctivitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344083


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

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01344083     History of Changes
Other Study ID Numbers: LT1210-PII-04/10
First Submitted: April 21, 2011
First Posted: April 28, 2011
Last Update Posted: October 12, 2017
Last Verified: April 2011

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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