MedTrace Logo

Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

NCT00889252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-03-06

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.

Conditions

  • Allergic Conjunctivitis

Interventions

DEVICE

contact lens with ketotifen

K-Lens (generic name not established) and Ketotifen combination drug-device product

DEVICE

contact lens

Placebo contact lens

Sponsors & Collaborators

  • Vistakon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Brian Pall, OD, MS, FAAO · Johnson & Johnson Vision Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889252 on ClinicalTrials.gov