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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754338

Enrollment

Registered

2008-09-18

Start date

2008-01-31

Completion date

2008-09-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ametropia

Keywords

comfort, wetability, protein deposit, lipid deposit

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.

Detailed description

Interventions

DRUGAlcon Opti-Free® RepleniSH® with Supraclens®

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

DRUGAlcon Opti-Free® RepleniSH®

Marketed Multipurpose Disinfecting Care System

DRUGB&L ReNu MultiPlus™

Marketed Multipurpose Disinfecting Care Systems

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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'.
Lens Wettability	4 weeks	Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Lens Deposits	4 weeks	Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).

Secondary

Measure	Time frame	Description
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'.
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'.
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.

Countries

Canada

Participant flow

Recruitment details

Recruitment started January 2008 at CCLR (Study completed July 2008)

Pre-assignment details

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.

Participants by arm

Arm	Count
Ph1: RepleniSH(No-rub) & Supraclens Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	17
Ph1: RepleniSH(Rub) Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	21
Ph2: RepleniSH(No-rub) & Supraclens Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.	19
Ph2: ReNu Multiplus(Rub) Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.	19
Total	76

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
First Intervention for Phase1&Phase2	Withdrawal by Subject	0	3	3	0
Second Intervention for Phase1&Phase2	Withdrawal by Subject	0	1	0	1

Baseline characteristics

Characteristic	Ph1: RepleniSH(Rub)	Ph2: RepleniSH(No-rub) & Supraclens	Ph1: RepleniSH(No-rub) & Supraclens	Ph2: ReNu Multiplus(Rub)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	21 Participants	19 Participants	17 Participants	19 Participants	76 Participants
Age, Continuous	21 years STANDARD_DEVIATION 3	30 years STANDARD_DEVIATION 9	28 years STANDARD_DEVIATION 11	24 years STANDARD_DEVIATION 7	26 years STANDARD_DEVIATION 9
Region of Enrollment Canada	21 participants	19 participants	17 participants	19 participants	76 participants
Sex: Female, Male Female	17 Participants	17 Participants	13 Participants	14 Participants	61 Participants
Sex: Female, Male Male	4 Participants	2 Participants	4 Participants	5 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Comfort

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