Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

• Sponsor: University of Waterloo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00754338
• Collaborator: Alcon Research (Industry)
• Enrollment: 76
• Location: 1
• Arms: 4
• Duration (Months): 8
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Drug: Alcon Opti-Free® RepleniSH®; Drug: B&L ReNu MultiPlus™	N/A

Detailed Description

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phase1 - Arm 1	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover; Drug: Alcon Opti-Free® RepleniSH®; Marketed Multipurpose Disinfecting Care System
Active Comparator: Phase1 - Arm 2	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover; Drug: Alcon Opti-Free® RepleniSH®; Marketed Multipurpose Disinfecting Care System
Active Comparator: Phase 2 - Arm 1	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover; Drug: B&L ReNu MultiPlus™; Marketed Multipurpose Disinfecting Care Systems
Active Comparator: Phase 2 - Arm 2	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover; Drug: B&L ReNu MultiPlus™; Marketed Multipurpose Disinfecting Care Systems

Outcome Measures

Primary Outcome Measures

1. Comfort [4 weeks]

   Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.

2. Lens Wettability [4 weeks]

   Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).

3. Lens Deposits [4 weeks]

   Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).

Secondary Outcome Measures

1. Dryness [4 weeks]

   Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.

2. Subjective Vision [4 weeks]

   Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.

3. Corneal Staining [4 weeks]

   Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer.

• Has read, understood and signed an information consent letter.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.

• Has clear corneas and no active ocular disease.

• Has had an ocular examination in the last two years.

• Is a current soft lens wearer, replacing their lenses every two weeks to one month.

• Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.

• Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

• Has any signs or symptoms of dry eye.

• Has any clinically significant blepharitis.

• Has undergone corneal refractive surgery.

• Is aphakic.

• Has any active ocular disease.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that may affect ocular health.

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

• Is pregnant or lactating.

• Is participating in any other type of clinical or research study.

• Currently wears daily disposable lenses.

• Currently wears lenses on an extended wear basis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Contact Lens Research, School of Optometry, University of Waterloo.	Waterloo	Ontario	Canada	N2L3G1

Sponsors and Collaborators

• University of Waterloo
• Alcon Research

Investigators

• Study Chair: Desmond Fonn, MOptom, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00754338
• Other Study ID Numbers: P/279/07/L
• First Posted: Sep 18, 2008
• Last Update Posted: Oct 5, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: comfort; wetability; protein deposit; lipid deposit
• Additional relevant MeSH terms: Refractive Errors; Dipivefrin

Study Results

Participant Flow

Recruitment Details	Recruitment started January 2008 at CCLR (Study completed July 2008)
Pre-assignment Detail	Phase 1 - 38 participants enrolled, Phase 2 - 38 participants enrolled. For both Phase 1 and 2 a washout period of at least one day, during which time participants wore spectacles and no contact lenses.

Arm/Group Title	Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)	Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens	Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)	Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
Period Title: First Intervention for Phase1&Phase2
STARTED	17	21	19	19
COMPLETED	17	18	16	19
NOT COMPLETED	0	3	3	0
Period Title: First Intervention for Phase1&Phase2
STARTED	17	18	16	19
COMPLETED	17	17	16	18
NOT COMPLETED	0	1	0	1

Baseline Characteristics

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)	Total
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Total of all reporting groups
Overall Participants	17	21	19	19	76
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	21 100%	19 100%	19 100%	76 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (11)	21 (3)	30 (9)	24 (7)	26 (9)
Sex: Female, Male (Count of Participants)
Female	13 76.5%	17 81%	17 89.5%	14 73.7%	61 80.3%
Male	4 23.5%	4 19%	2 10.5%	5 26.3%	15 19.7%
Region of Enrollment (participants) [Number]
Canada	17 100%	21 100%	19 100%	19 100%	76 100%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a scale]	86 (13)	86 (15)	87 (14)	86 (14)

2. Secondary Outcome

Title	Dryness
Description	Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a Scale]	85 (14)	86 (16)	85 (15)	85 (15)

3. Secondary Outcome

Title	Subjective Vision
Description	Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a scale]	89 (12)	89 (13)	90 (11)	90 (11)

4. Secondary Outcome

Title	Corneal Staining
Description	Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a scale]	47 (111)	55 (113)	52 (108)	322 (479)

5. Primary Outcome

Title	Lens Wettability
Description	Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a scale]	0.71 (0.49)	0.72 (0.38)	0.92 (0.68)	1.21 (0.69)

6. Primary Outcome

Title	Lens Deposits
Description	Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis was per protocol

Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Measure Participants	34	34	34	34
Mean (Standard Deviation) [Units on a scale]	0.51 (0.34)	0.54 (0.47)	0.62 (0.43)	0.93 (0.66)

Adverse Events

Time Frame	One business day to Office of Research Ethics
Adverse Event Reporting Description	No adverse events were reported for this study.
Arm/Group Title	Ph1: RepleniSH(No-rub) & Supraclens		Ph1: RepleniSH(Rub)		Ph2: RepleniSH(No-rub) & Supraclens		Ph2: ReNu Multiplus(Rub)
Arm/Group Description	Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.		Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.		Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.		Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
All Cause Mortality
	Ph1: RepleniSH(No-rub) & Supraclens		Ph1: RepleniSH(Rub)		Ph2: RepleniSH(No-rub) & Supraclens		Ph2: ReNu Multiplus(Rub)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ph1: RepleniSH(No-rub) & Supraclens		Ph1: RepleniSH(Rub)		Ph2: RepleniSH(No-rub) & Supraclens		Ph2: ReNu Multiplus(Rub)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Ph1: RepleniSH(No-rub) & Supraclens		Ph1: RepleniSH(Rub)		Ph2: RepleniSH(No-rub) & Supraclens		Ph2: ReNu Multiplus(Rub)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.