At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 310 enrolled
Drug / intervention
K-Lens (generic name not established) and Ketotifen +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
In Brief
A Phase 3 clinical trial evaluating K-Lens (generic name not established) and Ketotifen and Placebo Lens for Allergic Conjunctivitis. Completed, enrolled 310 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedDec 2007
Primary CompletionFeb 2008
Study CompletionMar 2008
TodayJul 2026
First PostedDec 7, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.6 years ago
Interventions
K-Lens (generic name not established) and Ketotifendevice
combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Lensdevice
contact lens without drug