NCT00331500

Brief Summary

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2006

Completed
Last Updated

August 14, 2017

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

May 30, 2006

Last Update Submit

August 10, 2017

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Daily ocular itching and redness scores

    Up to Day 14

Secondary Outcomes (1)

  • Percentage of patients with daily ocular itching and redness scores of 0

    Up to Day 14

Study Arms (2)

Olopatadine Hydrochloride 0.2%

EXPERIMENTAL

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Vehicle

PLACEBO COMPARATOR

Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks

Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%DRUG
Olopatadine Hydrochloride 0.2%
Olopatadine Hydrochloride Ophthalmic Solution VehicleDRUG

Inactive ingredients used as a placebo comparator

Vehicle

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

You may not qualify if:

  • Under 10 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • https://www.ncbi.nlm.nih.gov/pubmed/23379201

    RESULT

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alcon, A Novartis Company

    Alcon, a Novartis Company

    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

May 30, 2006

First Posted

May 31, 2006

Study Start

April 18, 2006

Primary Completion

July 27, 2006

Study Completion

July 27, 2006

Last Updated

August 14, 2017

Record last verified: 2008-06