AmetropiaNCT00754338

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

A study testing Alcon Opti-Free® RepleniSH® with Supraclens®, Alcon Opti-Free® RepleniSH® and B&L ReNu MultiPlus™ in people with Ametropia, run by University of Waterloo at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Ametropia
What is being tested?: Alcon Opti-Free® RepleniSH® with Supraclens®, Alcon Opti-Free® RepleniSH® and B&L ReNu MultiPlus™
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteCanada
Study dates: Jan 2008to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research, School of Optometry, University of Waterloo.
Waterloo, Ontario, N2L3G1

Other trials in Canada

About this study

Read the detailed description

Conditions: Ametropia
Being tested: Alcon Opti-Free® RepleniSH® with Supraclens®, Alcon Opti-Free® RepleniSH®, B&L ReNu MultiPlus™
Keywords: comfort, wetability, protein deposit, lipid deposit
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alcon Opti-Free® RepleniSH® with Supraclens®Drug
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Alcon Opti-Free® RepleniSH®Drug
Marketed Multipurpose Disinfecting Care System
B&L ReNu MultiPlus™Drug
Marketed Multipurpose Disinfecting Care Systems

Study groups in NCT00754338
Study group	Role	What they receive
Phase1 - Arm 1	Active comparator	Not described Receives: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Drug: Alcon Opti-Free® RepleniSH®
Phase1 - Arm 2	Active comparator	Not described Receives: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Drug: Alcon Opti-Free® RepleniSH®
Phase 2 - Arm 1	Active comparator	Not described Receives: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Drug: B&L ReNu MultiPlus™
Phase 2 - Arm 2	Active comparator	Not described Receives: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®; Drug: B&L ReNu MultiPlus™

What is being measured

The primary outcome is the main question the study is designed to answer.

Comfort
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Measured: 4 weeks
Lens Wettability
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Measured: 4 weeks
Lens Deposits
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Measured: 4 weeks

Secondary outcomes (3)

Dryness
Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Measured: 4 weeks
Subjective Vision
Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Measured: 4 weeks
Corneal Staining
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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Sep 2008

First posted18 Sep 2008 (estimated)
Study startJan 2008
Primary completionJul 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AmetropiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00754338
Sponsor's protocol ID: P/279/07/L
Status last verified: Sep 2023
First submitted: 17 Sep 2008
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
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All Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
ClinicalTrials.gov ID: NCT00754338
Acronym / sponsor ID: P/279/07/L
Conditions: Ametropia
Keywords: comfort, wetability, protein deposit, lipid deposit
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Alcon Research
Study start: Jan 2008
Primary completion: Jul 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 18 Sep 2008 (estimated)
Results: Posted 20 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Phase1 - Arm 1	Active comparator	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®, Drug: Alcon Opti-Free® RepleniSH®
Phase1 - Arm 2	Active comparator	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®, Drug: Alcon Opti-Free® RepleniSH®
Phase 2 - Arm 1	Active comparator	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®, Drug: B&L ReNu MultiPlus™
Phase 2 - Arm 2	Active comparator	Drug: Alcon Opti-Free® RepleniSH® with Supraclens®, Drug: B&L ReNu MultiPlus™

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alcon Opti-Free® RepleniSH® with Supraclens®Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover	Drug	Phase 2 - Arm 1, Phase 2 - Arm 2, Phase1 - Arm 1, Phase1 - Arm 2
Alcon Opti-Free® RepleniSH®Marketed Multipurpose Disinfecting Care System	Drug	Phase1 - Arm 1, Phase1 - Arm 2
B&L ReNu MultiPlus™Marketed Multipurpose Disinfecting Care Systems	Drug	Phase 2 - Arm 1, Phase 2 - Arm 2

Primary outcome

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

3 secondary outcomes

Dryness
Time frame: 4 weeks
Subjective Vision
Time frame: 4 weeks
Corneal Staining
Time frame: 4 weeks

Results and safety

Results posted to the registry on 20 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)	17	17
Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens	21	18
Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)	19	16
Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens	19	19

Primary outcome: Comfort

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Ph1: RepleniSH(No-rub) & Supraclens n = 34	Ph1: RepleniSH(Rub) n = 34	Ph2: RepleniSH(No-rub) & Supraclens n = 34	Ph2: ReNu Multiplus(Rub) n = 34
Value	86 (13)	86 (15)	87 (14)	86 (14)

Population analysed: analysis was per protocol

Primary outcome: Lens Wettability

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Ph1: RepleniSH(No-rub) & Supraclens n = 34	Ph1: RepleniSH(Rub) n = 34	Ph2: RepleniSH(No-rub) & Supraclens n = 34	Ph2: ReNu Multiplus(Rub) n = 34
Value	0.71 (0.49)	0.72 (0.38)	0.92 (0.68)	1.21 (0.69)

Population analysed: analysis was per protocol

Primary outcome: Lens Deposits

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Ph1: RepleniSH(No-rub) & Supraclens n = 34	Ph1: RepleniSH(Rub) n = 34	Ph2: RepleniSH(No-rub) & Supraclens n = 34	Ph2: ReNu Multiplus(Rub) n = 34
Value	0.51 (0.34)	0.54 (0.47)	0.62 (0.43)	0.93 (0.66)

Population analysed: analysis was per protocol

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: One business day to Office of Research Ethics. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ph1: RepleniSH(No-rub) & Supraclens	0 of 0	0 of 0	Not reported
Ph1: RepleniSH(Rub)	0 of 0	0 of 0	Not reported
Ph2: RepleniSH(No-rub) & Supraclens	0 of 0	0 of 0	Not reported
Ph2: ReNu Multiplus(Rub)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ametropia

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
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Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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Recruiting
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Desmond Fonn, MOptom study chair

University of Waterloo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alcon Opti-Free® RepleniSH® with Supraclens®, Alcon Opti-Free® RepleniSH® and B&L ReNu MultiPlus™ in people with Ametropia, run by University of Waterloo at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comfort (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00754338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.