NCT00775658

Brief Summary

Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

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

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

October 17, 2008

Results QC Date

February 21, 2017

Last Update Submit

June 12, 2017

Conditions

Allergic RhinitisAllergic Conjunctivitis

Keywords

allergyskin testingeye dropsantihistamines

Outcome Measures

Primary Outcomes (2)

  • The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.

    at baseline and at return visit (between study day 7-10)

  • The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.

    at baseline and at return visit (between study day 7-10)

Study Arms (2)

olopatadine then placebo

ACTIVE COMPARATOR

participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days

Drug: olopatadineDrug: placebo

placebo then olopatadine

ACTIVE COMPARATOR

participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days

Drug: olopatadineDrug: placebo

Interventions

olopatadineDRUG

olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day

olopatadine then placeboplacebo then olopatadine
placeboDRUG

placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

olopatadine then placeboplacebo then olopatadine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years
  • Healthy volunteers (no major illnesses or active symptoms)

You may not qualify if:

  • Known allergy or hypersensitivity to the drugs or components
  • Pregnant or nursing women
  • Women wishing to become pregnant during the study's duration
  • Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
  • Dermatographism as evidenced on skin testing on visit 1
  • Chronic urticaria active within the past 6 months
  • Severe hypertension
  • Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Asthma, Sinus and Allergy Program Research

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Rhinitis, AllergicConjunctivitis, AllergicHypersensitivity

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size and majority female patients.

Results Point of Contact

Title
John Fahrenholz, M.D.
Organization
Vanderbilt Medical Center
john.m.fahrenholz@vanderbilt.edu
615-936-2727

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)