MyopiaPhase 3AmethystNCT00520689
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
A Phase 3 study testing Silicone Hydrogel Contact Lens in people with Myopia and Hyperopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft). Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Silicone Hydrogel Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is at least 17 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 study appointment schedule
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
- Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
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- Has clear corneas and no active ocular disease
- Has had an ocular examination in the last two years.
- Has a functional pair of spectacles
- Is a current soft lens wearer replacing their lenses at least monthly
- Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
- Has astigmatism less than or equal to -1.00DC
- Agrees to wear the study lenses on a daily wear basis
Who cannot join
- A person will be excluded from the study if he/she:
- Has any signs or symptoms of dry eye
- Has any clinically significant blepharitis
- Has undergone corneal refractive surgery
- Is aphakic
- Has any systemic disease affecting ocular health
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- Is using any systemic or topical medications that may affect ocular health
- Is pregnant or lactating
- Is participating in any other type of clinical or research study
- Currently wears daily disposable lenses
- Currently wears lenses on a continuous or extended wear basis
- Is unable to successfully wear contact lenses without routinely using rewetting drops
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
Official title: Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).
Read the detailed description
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.
- Being tested
- Silicone Hydrogel Contact Lens
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Hydrogel Contact LensDevice
Also called Premio
use of lens over 2 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: Silicone Hydrogel Contact Lens |
| 2 | Active comparator | Not described Receives: Device: Silicone Hydrogel Contact Lens |
| 3 | Active comparator | Not described Receives: Device: Silicone Hydrogel Contact Lens |
| 4 | Active comparator | Not described Receives: Device: Silicone Hydrogel Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see if there are any effects on the cornea when using each contact lens/solution combination.
Measured: Over 2 days
Secondary outcomes (1)
To quantify comfort and vision ratings with each lens/solution combination.
Measured: over 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Investigators
- Desmond Fonn, M Optom, Principal investigator, University of WaterlooCraig Woods, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520689
- Sponsor's protocol ID
- P/264/07/M
- Acronym
- Amethyst
- Status last verified
- Feb 2009
- First submitted
- 22 Aug 2007
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT00520689
- Acronym / sponsor ID
- Amethyst / P/264/07/M
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).
Detailed description
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Silicone Hydrogel Contact Lens |
| 2 | Active comparator | Device: Silicone Hydrogel Contact Lens |
| 3 | Active comparator | Device: Silicone Hydrogel Contact Lens |
| 4 | Active comparator | Device: Silicone Hydrogel Contact Lens |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Is at least 17 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 study appointment schedule
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
- Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
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 systemic disease affecting 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 |
|---|---|---|
| Silicone Hydrogel Contact LensAlso: Premiouse of lens over 2 days | Device | 1, 2, 3, 4 |
Primary outcome
To see if there are any effects on the cornea when using each contact lens/solution combination.
Time frame: Over 2 days
1 secondary outcome
To quantify comfort and vision ratings with each lens/solution combination.
Time frame: over 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
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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
Craig Woods, PhD 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?
A Phase 3 study testing Silicone Hydrogel Contact Lens in people with Myopia and Hyperopia, 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 13 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 16 Feb 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To see if there are any effects on the cornea when using each contact lens/solution combination. (time frame: Over 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2009.