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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:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01344083
First received: April 21, 2011
Last updated: April 11, 2012
Last verified: April 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Change from baseline of the score of tearing [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline of the score of itching [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline of the score of conjunctival hyperaemia [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01344083     History of Changes
Other Study ID Numbers: LT1210-PII-04/10
Study First Received: April 21, 2011
Last Updated: April 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Tunisia: Ministry of Public Health

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013