NCT00987272

Brief Summary

The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

September 28, 2009

Last Update Submit

July 28, 2014

Conditions

Allergic Conjunctivitis

Keywords

AllergiesOcular

Outcome Measures

Primary Outcomes (1)

  • Mean Ocular Itching Score

    Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary Outcomes (1)

  • Mean Total Redness Score

    Day 0 of treatment: 3, 10, 20 minutes post-CAC

Study Arms (2)

Pataday+Pataday Vehicle

EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Drug: Olopatadine 0.2% Vehicle

Patanol+Patanol Vehicle

ACTIVE COMPARATOR

Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1%Drug: Olopatadine 0.1% Vehicle

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%DRUG
Also known as: PATADAY®
Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%DRUG
Also known as: PATANOL®
Patanol+Patanol Vehicle
Olopatadine 0.2% VehicleDRUG

Inactive ingredients used as placebo comparator

Pataday+Pataday Vehicle
Olopatadine 0.1% VehicleDRUG

Inactive ingredients used as placebo comparator

Patanol+Patanol Vehicle

Eligibility Criteria

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

You may qualify if:

  • Japanese ethnicity.
  • Seasonal Allergic Conjunctivitis--asymptomatic.

You may not qualify if:

  • Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (\>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching \>0) at the start of any visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctivitis, AllergicHypersensitivity

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pamela Smith, BS

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2009

First Posted

September 30, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 31, 2014

Record last verified: 2014-07