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Completed

NCT Number: NCT01344083

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

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.

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Key information

Conditions

Seasonal Allergic Conjunctivitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pierre Huguet

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion criteria

  • Severe ocular allergy
  • Vernal keratoconjunctivitis

Treatment and study plan

T1210

Drug

2 drops T1210 once a day

Olopatadine hydrochloride

Drug

2 drops once a day Olopatadine

Primary outcomes

  1. Change from baseline of the score of tearing

    Time frame: Day 28

  2. Change from baseline of the score of itching

    Time frame: Day 28

  3. Change from baseline of the score of conjunctival hyperaemia

    Time frame: Day 28

Secondary outcomes

  1. Global local tolerance assessment by the Investigator and the patient

    Time frame: Day 7

  2. Global local tolerance assessment by the Investigator and the patient

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 28, 2011
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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