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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Bioclean MPS VII; Device: Aosept Clearcare; Device: comfilcon A

• Registration Number: NCT02537730
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-02
• Primary Completion: 2015-10
• Study Completion: 2016-06
• Results First Submitted: 2016-06-10
• Results First Submitted QC: 2016-09-06
• Results First Posted: 2016-09-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bioclean MPS VII / comfilcon A combination	comfilcon A	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII / comfilcon A combination	Bioclean MPS VII	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Aosept Clearcare / comfilcon A combination	comfilcon A	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare / comfilcon A combination	Aosept Clearcare	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Ocular Health - Corneal Staining	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Comfort	1 week	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.
Dryness	1 week	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.
Stinging and Burning Sensation	Baseline	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.

Trial Locations

Locations (3)

Iwasaki Eye Clinic; 🇯🇵 Osaka-shi, Osaka-fu, Japan

Kodama Eye Clinic; 🇯🇵 Joyo-shi, Kyoto-fu, Japan

Higashihara Eye Clinic; 🇯🇵 Kameoka, Kyoto-fu, Japan