NCT00389025

Brief Summary

To assess the effects of olopatadine of the release of mast cell histamine

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

November 22, 2016

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

October 13, 2006

Last Update Submit

November 18, 2016

Conditions

Allergic Conjunctivitis

Keywords

Subject with clinical history of seasonal allergic conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Tear histamine

Secondary Outcomes (1)

  • Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness

Interventions

Olopatadine (generic name)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic and not using any topical or systemic medication

You may not qualify if:

  • Age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Padova Site

Padua, Padova, Italy

Location

Related Links

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Terry Wiernas

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 17, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Last Updated

November 22, 2016

Record last verified: 2010-01

Locations

IT(1)