BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Myopia Clinical Trial

Official title:

BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537730
• Other study ID #: CVJ-EX-MKTG-1318
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (Diopters) 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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Bioclean MPS VII
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
• Aosept Clearcare
Hydrogen Peroxide Disinfecting and Cleaning system
• comfilcon A
contact lens

Locations

Country	Name	City	State
Japan	Kodama Eye Clinic	Joyo-shi	Kyoto-fu
Japan	Higashihara Eye Clinic	Kameoka	Kyoto-fu
Japan	Iwasaki Eye Clinic	Osaka-shi	Osaka-fu

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Health - Corneal Staining	Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.	1 week
Secondary	Comfort	Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.	1 week
Secondary	Dryness	Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.	1 week
Secondary	Stinging and Burning Sensation	Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.	Baseline