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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02537730
• Collaborator: (none)
• Enrollment: 33
• Locations: 3
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 11
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Bioclean MPS VII; Device: Aosept Clearcare; Device: comfilcon A	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bioclean MPS VII / comfilcon A combination Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.	Device: Bioclean MPS VII; PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system; Device: comfilcon A; contact lens; Other Names: Biofinity
Active Comparator: Aosept Clearcare / comfilcon A combination Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.	Device: Aosept Clearcare; Hydrogen Peroxide Disinfecting and Cleaning system; Device: comfilcon A; contact lens; Other Names: Biofinity

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kodama Eye Clinic	Joyo-shi	Kyoto-fu	Japan	610-0121
2	Higashihara Eye Clinic	Kameoka	Kyoto-fu	Japan	621-0861
3	Iwasaki Eye Clinic	Osaka-shi	Osaka-fu	Japan	542-0082

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Yuji Kodama, MD, PhD, Kodama Eye Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02537730
• Other Study ID Numbers: CVJ-EX-MKTG-1318
• First Posted: Sep 2, 2015
• Last Update Posted: Aug 18, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Bioclean MPS VII Combo, Then Aosept Clearcare Combo	Aosept Clearcare Combo, Then Bioclean MPS VII Combo
Arm/Group Description	Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens
Period Title: First Intervention (7 Days)
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0
Period Title: First Intervention (7 Days)
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (12)
Sex: Female, Male (Count of Participants)
Female	24 72.7%
Male	9 27.3%

Outcome Measures

1. Primary Outcome

Title	Ocular Health - Corneal Staining
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bioclean MPS VII / Comfilcon A Combination	Aosept Clearcare / Comfilcon A Combination
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens
Measure Participants	33	33
Measure Eyes	66	66
Normal	45	53
Trace	21	13
Mild	0	0
Moderate	0	0
Severe	0	0

2. Secondary Outcome

Title	Comfort
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bioclean MPS VII / Comfilcon A Combination	Aosept Clearcare / Comfilcon A Combination
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens
Measure Participants	33	33
After insertion	9.24 (1.42)	9.30 (1.54)
After 4 hours of wear	9.52 (0.71)	9.44 (1.05)
After 8 hours of wear	8.99 (1.03)	9.10 (1.16)
Before removal	8.55 (1.13)	8.65 (1.39)
All day comfort	9.15 (0.85)	8.89 (1.14)

3. Secondary Outcome

Title	Dryness
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bioclean MPS VII / Comfilcon A Combination	Aosept Clearcare / Comfilcon A Combination
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens
Measure Participants	33	33
After Insertion	9.67 (0.69)	9.77 (0.65)
After 4 hours of wear	9.27 (0.87)	9.38 (0.86)
After 8 hours of wear	8.65 (1.22)	8.91 (1.03)
Before removal	8.26 (1.29)	8.33 (1.35)
All day dryness	8.92 (1.00)	8.92 (1.00)

4. Secondary Outcome

Title	Stinging and Burning Sensation
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bioclean MPS VII / Comfilcon A Combination	Aosept Clearcare / Comfilcon A Combination
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens
Measure Participants	33	33
Stinging Sensation	9.42 (0.93)	9.50 (0.93)
Burning Sensation	9.97 (0.17)	9.91 (0.38)

Adverse Events

Time Frame	From dispense up to two weeks for each study lenses
Arm/Group Title	Bioclean MPS VII / Comfilcon A Combination		Aosept Clearcare / Comfilcon A Combination
Arm/Group Description	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens		Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens
All Cause Mortality
	Bioclean MPS VII / Comfilcon A Combination		Aosept Clearcare / Comfilcon A Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bioclean MPS VII / Comfilcon A Combination		Aosept Clearcare / Comfilcon A Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Bioclean MPS VII / Comfilcon A Combination		Aosept Clearcare / Comfilcon A Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.