NCT00655109

Brief Summary

To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Shorter than 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

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

April 9, 2008

Status Verified

April 1, 2008

Enrollment Period

29 days

First QC Date

April 2, 2008

Last Update Submit

April 2, 2008

Conditions

Conjunctivitis, Allergic

Keywords

Allergic conjunctivitisAllergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ocular itching

    Minutes following CAC

Secondary Outcomes (1)

  • Ocular redness

    Minutes following CAC

Study Arms (4)

1

ACTIVE COMPARATOR

Olopatadine

Drug: Olopatadine

2

ACTIVE COMPARATOR

Fluticasone

Drug: Fluticasone

3

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Saline

4

PLACEBO COMPARATOR

Placebo Eyedrops

Drug: Artificial tears

Interventions

OlopatadineDRUG

Ophthalmic solution

1
FluticasoneDRUG

Nasal spray

2
SalineDRUG

Nasal spray

3
Artificial tearsDRUG

Ophthalmic Solution

4

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age \& either sex, any race
  • Willing and able to follow all instructions and attend all study visits
  • Positive history of ocular allergies
  • Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

You may not qualify if:

  • Have planned surgery during trial period
  • Female currently pregnant, planning a pregnancy, or lactating
  • Use of disallowed medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Associates, Inc

North Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine HydrochlorideFluticasoneSodium ChlorideLubricant Eye Drops

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • Jack V Greiner, OD, DO, PhD

    ORA, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 9, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 9, 2008

Record last verified: 2008-04

Locations

US(1)