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CompletedNCT01344083Updated Apr 12, 2012

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

A Phase 2 interventional study of T1210 and Olopatadine hydrochloride in Seasonal Allergic Conjunctivitis, sponsored by Laboratoires Thea. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-12.

Sponsored by Laboratoires Thea · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Seasonal Allergic Conjunctivitis
03

In context

Lead sponsor

Laboratoires Thea is the lead sponsor of 64 studies on the registry; 7 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Browse Laboratoires Thea studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written informed consent
  • Conjunctivitis allergic conjunctivitis

Exclusion criteria

Exclusion Criteria:

  • Severe ocular allergy
  • Vernal keratoconjunctivitis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    T1210

    Drug: T1210

  • Active comparator
    Olopatadine hydrochloride

    Drug: Olopatadine hydrochloride

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Pierre Huguet
    Clermont-Ferrand, 63000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01344083
Lead sponsor
Laboratoires Thea
Responsible party
Sponsor
First posted
Apr 28, 2011
Start date
Apr 2011
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Apr 12, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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