NCT01344083

CompletedPhase 2

Comparison of the Efficacy and Tolerability of T1210 and Olo...

Laboratoires Thea Source

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Other study identifiers

Sponsor study identifier

LT1210-PII-04/10

Study Type

interventional

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2012

Actual (reported)

Study Completion

February 2012

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 60 participants
Study completion date: February 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 21, 2011
Actual (reported)
First Posted
April 28, 2011
Actual (reported)
Primary Completion
February 2012
Actual (reported)
Study Completion
February 2012
Actual (reported)

Last Updated: April 12, 2012
Status Verified: April 2011
Last Update Submitted: April 11, 2012

Conditions

Seasonal Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (3)

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 Outcomes (2)

Global local tolerance assessment by the Investigator and the patient
Day 7
Global local tolerance assessment by the Investigator and the patient
Day 28

Study Arms (2)

T1210

EXPERIMENTAL

Drug: T1210

Olopatadine hydrochloride

ACTIVE COMPARATOR

Drug: Olopatadine hydrochloride

Interventions

T1210Drug

2 drops T1210 once a day

T1210

Olopatadine hydrochlorideDrug

2 drops once a day Olopatadine

Olopatadine hydrochloride

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent
Conjunctivitis allergic conjunctivitis

You may not qualify if:

Sponsors & Collaborators

Laboratoires Thea
Industrylead

Study Sites (1)

Pierre Huguet

Clermont-Ferrand, 63000, France

MeSH Terms

Interventions

Olopatadine Hydrochloride

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 28, 2011

Study Start

April 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2012

Actual (reported)

Phase 3Unknown

NCT06212973

A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients

Phase 3Completed

NCT01541904

Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

Phase 2Withdrawn

NCT00794144

Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

Phase 2Completed

NCT01272089

A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Phase 4Completed

NCT03444506

Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 2Completed

NCT01109485

Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

Phase 4Completed

Severe ocular allergy
Vernal keratoconjunctivitis

Contact the study team to confirm eligibility.

Study Completion

February 2012

Actual (reported)

Last Updated

April 12, 2012

Record last verified: 2011-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01344083
Data provider: ClinicalTrials.gov
Source updated: 2012-04-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:03 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

T1210

Olopatadine hydrochloride

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations