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

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ClinicalTrials.gov Identifier: NCT01344083
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

April 21, 2011
April 28, 2011
April 12, 2012
April 2011
February 2012   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01344083 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
Not Provided
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Seasonal Allergic Conjunctivitis
  • Drug: T1210
    2 drops T1210 once a day
  • Drug: Olopatadine hydrochloride
    2 drops once a day Olopatadine
  • Experimental: T1210
    Intervention: Drug: T1210
  • Active Comparator: Olopatadine hydrochloride
    Intervention: Drug: Olopatadine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

  • Severe ocular allergy
  • Vernal keratoconjunctivitis
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01344083
LT1210-PII-04/10
Not Provided
Not Provided
Not Provided
Laboratoires Thea
Laboratoires Thea
Not Provided
Not Provided
Laboratoires Thea
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP