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

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01344083
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Conjunctivitis	Drug: T1210; Drug: Olopatadine hydrochloride	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T1210	Drug: T1210; 2 drops T1210 once a day
Active Comparator: Olopatadine hydrochloride	Drug: Olopatadine hydrochloride; 2 drops once a day Olopatadine

Outcome Measures

Primary Outcome Measures

1. Change from baseline of the score of tearing [Day 28]

2. Change from baseline of the score of itching [Day 28]

3. Change from baseline of the score of conjunctival hyperaemia [Day 28]

Secondary Outcome Measures

1. Global local tolerance assessment by the Investigator and the patient [Day 7]

2. Global local tolerance assessment by the Investigator and the patient [Day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent

• Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

• Severe ocular allergy

• Vernal keratoconjunctivitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pierre Huguet	Clermont ferrand		France	63000

Sponsors and Collaborators

• Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT01344083
• Other Study ID Numbers: LT1210-PII-04/10
• First Posted: Apr 28, 2011
• Last Update Posted: Apr 12, 2012
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Olopatadine Hydrochloride

Study Results

No Results Posted as of Apr 12, 2012