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

Seasonal Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344083
• Other study ID #: LT1210-PII-04/10
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2011
• Last updated: April 11, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2011
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

• Severe ocular allergy

• Vernal keratoconjunctivitis

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Seasonal Allergic Conjunctivitis

Intervention

Drug:
• T1210
2 drops T1210 once a day
• Olopatadine hydrochloride
2 drops once a day Olopatadine

Locations

Country	Name	City	State
France	Pierre Huguet	Clermont ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the score of tearing		Day 28
Primary	Change from baseline of the score of itching		Day 28
Primary	Change from baseline of the score of conjunctival hyperaemia		Day 28
Secondary	Global local tolerance assessment by the Investigator and the patient		Day 7
Secondary	Global local tolerance assessment by the Investigator and the patient		Day 28