MyopiaPhase 4NCT00455455

Corneal and Conjunctival Sensitivity and Staining Study

A Phase 4 study testing Optifree RepleniSH Multipurpose Disinfecting Solution and ReNu Multiplus Multipurpose Solution in people with Myopia and Hyperopia, 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

Search all trials

Trial summary

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Read more about this study

Who is it for?: Ages 17 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Optifree RepleniSH Multipurpose Disinfecting Solution and ReNu Multiplus Multipurpose Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteCanada
Study dates: Mar 2007to Dec 2008
Phase: Phase 4
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 to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

An eligible participant is one who:
Is between 17-45 years old and has full legal capacity to volunteer.
Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
Is willing and able to follow instructions and maintain the appointment schedule.
Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.

Show all 12Show fewer

Has normal binocular vision (no strabismus, no amblyopia).
Has clear corneas and no active ocular disease.
Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
Has astigmatism less than or equal to -1.00DC.
Agrees to wear the study lenses on a daily wear basis.
Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Who cannot join

A person is ineligible if he/she:
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.

Show all 16Show fewer

Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Is pregnant or lactating.
Is participating in any other clinical or research study.
Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
Has ocular or systemic allergies that could adversely affect contact lens wear.
Currently wears lenses on a continuous or extended wear basis.
Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
Is a rigid lens wearer.
Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research, School of Optometry
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Read the detailed description

Conditions: Myopia, Hyperopia
Being tested: Optifree RepleniSH Multipurpose Disinfecting Solution, ReNu Multiplus Multipurpose Solution
Medical subject headings: Myopia, Hyperopia

What participants receive

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

Optifree RepleniSH Multipurpose Disinfecting SolutionDrug
Also called lens care system
lens care system
ReNu Multiplus Multipurpose SolutionDrug
Also called lens care system
lens care system

Study groups in NCT00455455
Study group	Role	What they receive
Optifree RepleniSH Multipurpose Disinfecting Solution	Active comparator	Not described Receives: Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
ReNu Multiplus Multipurpose Solution	Active comparator	Not described Receives: Drug: ReNu Multiplus Multipurpose Solution

What is being measured

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

Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Measured: baseline
Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Measured: day 7
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Measured: baseline
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Measured: day 7

Secondary outcomes (2)

Corneal Staining Grade
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Measured: baseline
Corneal Staining Grade
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Measured: day 7

Timeline

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

Mar 2007Dec 2008

First posted3 Apr 2007 (estimated)
Study startMar 2007
Primary completionDec 2008
Study completionDec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00455455
Sponsor's protocol ID: P/245/06/L
Status last verified: Jun 2010
First submitted: 23 Mar 2007
Last updated: 12 Jul 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Situ P, Simpson TL, Jones LW, Fonn D. Effects of silicone hydrogel contact lens wear on ocular surface sensitivity to tactile, pneumatic mechanical, and chemical stimulation. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6111-7. doi: 10.1167/iovs.09-4807. Epub 2010 Jun 30.
PubMed 20592230

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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corneal and Conjunctival Sensitivity and Staining Study
ClinicalTrials.gov ID: NCT00455455
Acronym / sponsor ID: P/245/06/L
Conditions: Myopia, Hyperopia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Alcon Research
Study start: Mar 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 3 Apr 2007 (estimated)
Results: Posted 12 Jul 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Optifree RepleniSH Multipurpose Disinfecting Solution	Active comparator	Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
ReNu Multiplus Multipurpose Solution	Active comparator	Drug: ReNu Multiplus Multipurpose Solution

Who may qualify

Ages: 17 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

Is between 17-45 years old and has full legal capacity to volunteer.
Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
Is willing and able to follow instructions and maintain the appointment schedule.
Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.

Key exclusion criteria (16 listed)

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.

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
Optifree RepleniSH Multipurpose Disinfecting SolutionAlso: lens care systemlens care system	Drug	Optifree RepleniSH Multipurpose Disinfecting Solution
ReNu Multiplus Multipurpose SolutionAlso: lens care systemlens care system	Drug	ReNu Multiplus Multipurpose Solution

Primary outcome

Corneal Sensitivity
Time frame: baseline
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Corneal Sensitivity
Time frame: day 7
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Conjunctival Sensitivity
Time frame: baseline
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Conjunctival Sensitivity
Time frame: day 7
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

2 secondary outcomes

Corneal Staining Grade
Time frame: baseline
Corneal Staining Grade
Time frame: day 7

Results and safety

Results posted to the registry on 12 Jul 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
RepleniSH First, Then ReNu	25	25
ReNu First, Then RepleniSH	25	24

Primary outcome: Corneal Sensitivity

Time frame: baseline. Mean (Standard Deviation). Unit: percent CO2

Measure	RepleniSH n = 48	ReNu n = 48
Value	26.9 (13.0)	25.5 (12.9)

Population analysed: intent to treat analysis including only participants who had completed the study

Primary outcome: Corneal Sensitivity

Time frame: day 7. Mean (Standard Deviation). Unit: percent CO2

Measure	RepleniSH n = 48	ReNu n = 48
Value	25.5 (13.4)	22.1 (13.8)

Population analysed: intent to treat analysis including only participants who had completed the study

Primary outcome: Conjunctival Sensitivity

Time frame: baseline. Mean (Standard Deviation). Unit: percent CO2

Measure	RepleniSH n = 48	ReNu n = 48
Value	48.7 (20.2)	49.6 (18.7)

Population analysed: intent to treat analysis including only participants who had completed the study

Primary outcome: Conjunctival Sensitivity

Time frame: day 7. Mean (Standard Deviation). Unit: percent CO2

Measure	RepleniSH n = 48	ReNu n = 48
Value	50.5 (20.2)	46.2 (22.4)

Population analysed: intent to treat analysis including only participants who had completed the study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RepleniSH	0 of 48 (0%)	0 of 48 (0%)	Not reported
ReNu	0 of 48 (0%)	0 of 48 (0%)	Not reported

Limitations and caveats (from the sponsor): Sample size completed as anticipated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20592230Situ P, Simpson TL, Jones LW, Fonn D. Effects of silicone hydrogel contact lens wear on ocular surface sensitivity to tactile, pneumatic mechanical, and chemical stimulation. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6111-7. doi: 10.1167/iovs.09-4807. Epub 2010 Jun 30.

Related trials for Myopia

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
Myopia

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, M.Optom principal investigator

University of Waterloo

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

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 16 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 12 Jul 2010. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 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?

Corneal Sensitivity (time frame: baseline). The study lists 4 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 NCT00455455, which also lists 1 linked publication.

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 12 Jul 2010.