Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
NCT ID: NCT00889252
Last Updated: 2015-03-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
NCT00569777
Clinical Evaluation of Etafilcon A With Ketotifen
NCT03388138
Clinical Evaluation of Approved Contact Lenses
NCT02699593
Clinical Evaluation of Multifocal Toric Contact Lenses
NCT03208088
Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses
NCT02625233
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
K-Lens
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens with ketotifen
K-Lens (generic name not established) and Ketotifen combination drug-device product
Placebo Lens
Placebo lens
contact lens
Placebo contact lens
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
contact lens with ketotifen
K-Lens (generic name not established) and Ketotifen combination drug-device product
contact lens
Placebo contact lens
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* normal ocular health
* contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye
Exclusion Criteria
* history of ocular surgery
* use of topical ophthalmic preparations (including rewetting drops)
* pregnancy or lactation
8 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vistakon Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Pall, OD, MS, FAAO
Role: STUDY_DIRECTOR
Johnson & Johnson Vision Care, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR-4539
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.