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

Phase 2

Completed

• Conditions: Seasonal Allergic Conjunctivitis
• Interventions: Drug: T1210; Drug: Olopatadine hydrochloride

• Registration Number: NCT01344083
• Lead Sponsor: Laboratoires Thea

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-04-11
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Written informed consent
• Conjunctivitis allergic conjunctivitis

Exclusion Criteria

• Severe ocular allergy
• Vernal keratoconjunctivitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T1210	T1210	-
Olopatadine hydrochloride	Olopatadine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Change from baseline of the score of tearing	Day 28
Change from baseline of the score of itching	Day 28
Change from baseline of the score of conjunctival hyperaemia	Day 28

Secondary Outcome Measures

Name	Time	Method
Global local tolerance assessment by the Investigator and the patient	Day 28

Trial Locations

Locations (1)

Pierre Huguet; 🇫🇷 Clermont ferrand, France