Overview

This trial is active, not recruiting.

Condition myopia
Treatments bioclean mps vii, aosept clearcare, comfilcon a contact lens
Phase phase 4
Sponsor Coopervision, Inc.
Start date September 2015
End date October 2015
Trial size 30 participants
Trial identifier NCT02537730, CVJ-MKTG-1318

Summary

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system for all available Soft Contact Lenses used in combination with comfilcon soft contact lens
bioclean mps vii
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system for all available Soft Contact Lenses
comfilcon a contact lens
contact lens
(Active Comparator)
Hydrogen Peroxide Disinfecting and Cleaning system for all available Soft Contact Lenses used in combination with comfilcon soft contact lens
aosept clearcare
Hydrogen Peroxide Disinfecting and Cleaning system for all available Soft Contact Lenses
comfilcon a contact lens
contact lens

Primary Outcomes

Measure
Biomicroscopy - Anterior Ocular Health, Cornea - BIOCLEAN MPS VII / comfilcon A assessed by slit lamp
time frame: Change from Baseline over 1 week
Biomicroscopy - Anterior Ocular Health, Cornea - AOSEPT CLEARCARE / comfilcon A assessed by slit lamp
time frame: Change from Baseline over 1 week

Secondary Outcomes

Measure
Comfort Scale - BIOCLEAN MPS VII / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Comfort Scale - BIOCLEAN MPS VII / comfilcon A
time frame: 1 week follow-up Visit
Comfort Scale - AOSEPT CLEARCARE / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Comfort Scale - AOSEPT CLEARCARE / comfilcon A
time frame: 1 week follow-up Visit
Dryness Scale - BIOCLEAN MPS VII / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Dryness Scale - BIOCLEAN MPS VII / comfilcon A
time frame: 1 week follow-up Visit
Dryness Scale - AOSEPT CLEARCARE / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Dryness Scale - AOSEPT CLEARCARE / comfilcon A
time frame: 1 week follow-up Visit
Stinging and Burning Sensation Scale - BIOCLEAN MPS VII / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Stinging and Burning Sensation Scale - BIOCLEAN MPS VII / comfilcon A
time frame: 1 week follow-up Visit
Stinging and Burning Sensation Scale - AOSEPT CLEARCARE / comfilcon A
time frame: After settling of the lenses at the Dispense Visit
Stinging and Burning Sensation Scale - AOSEPT CLEARCARE / comfilcon A
time frame: 1 week follow-up Visit

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Is over 18 years of age (inclusive) - Has had a self-reported visual exam in the last two years - Has a CL (contact lens) spherical prescription between -0.25D and -12.00D (inclusive) - Has less than 1.00 D spectacle cylinder in each eye - Is correctable to a visual acuity of 20/20 or better in both eyes - Has clear corneas and no active ocular disease - Has read, understood and signed the informed consent letter - Is willing to comply with the wear schedule (at least 40hrs per week) - Is willing to comply with the visit schedule Exclusion Criteria: - Has never worn contact lenses before - Currently wears rigid gas permeable contact lens - Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day) - Has a CL prescription outside the range of -0.25D to -12.00D - Has a spectacle cylinder greater than -0.75D of cylinder in either eye - Has best corrected spectacle distant vision worse than 20/20 in ether eye - Has any systemic disease affecting ocular health - Is using any systemic or topical medications that will affect ocular health - Has any ocular pathology or sever insufficiency of lacrimal secretion - Has persistent, clinically significant corneal or conjunctival staining - Has active neovascularization or any central corneal scars - Is aphakic - Is pregnant or lactating

Additional Information

Official title BIOCLEAN MPS VII in Combination With Biofinity Lens: A Two Week Crossover Study
Principal investigator Yuji Kodama, MD, PhD
Description To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Coopervision, Inc..