Clear Care® Plus vs. PeroxiClear™

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02413333
• Collaborator: (none)
• Enrollment: 133
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses	N/A

Detailed Description

Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Clear Care Plus, then PeroxiClear Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.	Device: Clear Care Plus contact lens solution; 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses; Other Names: Clear Care Plus ; Device: PeroxiClear contact lens solution; 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses; Other Names: PeroxiClear ; Device: Silicone hydrogel contact lenses; 2-week/monthly replacement contact lenses per participant's habitual brand
Other: PeroxiClear, then Clear Care Plus PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.	Device: Clear Care Plus contact lens solution; 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses; Other Names: Clear Care Plus ; Device: PeroxiClear contact lens solution; 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses; Other Names: PeroxiClear ; Device: Silicone hydrogel contact lenses; 2-week/monthly replacement contact lenses per participant's habitual brand

Outcome Measures

Primary Outcome Measures

1. Mean Residual Peroxide at Day 30 [Day 30, each product]

   The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Secondary Outcome Measures

1. Mean Osmolality in Lens Cases at Day 30 [Day 30, each product]

   The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign informed consent form;

• Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);

• Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;

• Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Current hydrogen peroxide-based solution user;

• Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

• Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;

• Use of systemic or ocular medications for which contact lens wear could be contraindicated;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, Vision Care, Global Medical Affairs, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02413333
• Other Study ID Numbers: LCD913-P001
• First Posted: Apr 9, 2015
• Last Update Posted: Sep 19, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Alcon Research: Contact lens solution
• Additional relevant MeSH terms: Refractive Errors; Contact Lens Solutions; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Participants were recruited from ten investigational centers located in the United States.
Pre-assignment Detail	All randomized participants (132). One enrolled participant discontinued prior to randomization.

Arm/Group Title	Clear Care Plus, Then PeroxiClear	PeroxiClear, Then Clear Care Plus
Arm/Group Description	Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.	PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Period Title: Period 1
STARTED	66	66
Randomized and Treated	66	66
COMPLETED	65	65
NOT COMPLETED	1	1
Period Title: Period 1
STARTED	65	65
COMPLETED	64	65
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Clear Care Plus, Then PeroxiClear	PeroxiClear, Then Clear Care Plus	Clear Care Plus, Then Clear Care Plus	PeroxiClear, Then PeroxiClear	Total
Arm/Group Description	Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.	PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.	Clear Care Plus was used in Period 1 and in Period 2.	PeroxiClear was used in Period 1 and in Period 2.	Total of all reporting groups
Overall Participants	65	65	1	1	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.7 (11.2)	35.7 (11.8)	42.0 (NA)	38.0 (NA)	36.7 (11.4)
Age, Customized (participants) [Number]
18-64 years	65 100%	64 98.5%	1 100%	1 100%	131 99.2%
≥65 years	0 0%	1 1.5%	0 0%	0 0%	1 0.8%
Sex: Female, Male (Count of Participants)
Female	52 80%	49 75.4%	1 100%	1 100%	103 78%
Male	13 20%	16 24.6%	0 0%	0 0%	29 22%

Outcome Measures

1. Primary Outcome

Title	Mean Residual Peroxide at Day 30
Description	The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time Frame	Day 30, each product

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	PeroxiClear	Clear Care Plus
Arm/Group Description	PeroxiClear Lens Cases	Clear Care Plus Lens Cases
Measure Participants	132	132
Measure Lens Cases	130	130
Mean (Standard Deviation) [parts per million (ppm)]	229.7 (280.13)	26.2 (41.17)

2. Secondary Outcome

Title	Mean Osmolality in Lens Cases at Day 30
Description	The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time Frame	Day 30, each product

Outcome Measure Data

Analysis Population Description

Intention to treat participants with non-missing observations

Arm/Group Title	PeroxiClear	Clear Care Plus
Arm/Group Description	PeroxiClear Lens Cases	Clear Care Plus Lens Cases
Measure Participants	132	132
Measure Lens Cases	130	130
Mean (Standard Deviation) [milliosmoles/kg (mOsm/kg)]	345.1 (11.76)	299.2 (7.63)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 60 [+10] days).
Adverse Event Reporting Description	AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.
Arm/Group Title	PeroxiClear		Clear Care Plus
Arm/Group Description	While using PeroxiClear		While using Clear Care Plus
All Cause Mortality
	PeroxiClear		Clear Care Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PeroxiClear		Clear Care Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	PeroxiClear		Clear Care Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/130 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.