MyopiaPhase 3NCT00520351
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
A Phase 3 study testing ClearCare and Optifree Replenish in people with Myopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- ClearCare and Optifree Replenish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 3
- 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
- A person is eligible for inclusion in the study if he/she:
- 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 presently using either bi-weekly or monthly replacement lenses.
- Has symptoms of ocular dryness as determined by specific pre-screening criteria.
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- 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.
Who cannot join
- A person will be excluded from the study if he/she:
- Is an asymptomatic lens wearer.
- Is a daily disposable contact lens wearer.
- Is a current extended wear contact lens wearer.
- Currently uses one of the study lens care regimens.
- Has any clinically significant blepharitis.
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- 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 participating in any other type of clinical or research study.
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
About this study
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Read the detailed description
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings
- Conditions
- Myopia
- Being tested
- ClearCare, Optifree Replenish
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearCareDrug
contact lens care system
Optifree ReplenishDrug
contact lens care system
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: ClearCare |
| 2 | Active comparator | Not described Receives: Drug: Optifree Replenish |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Contrast Visual Acuity
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.
10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Measured: 2 weeks
Low Contrast Visual Acuity
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.
10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Measured: 2 weeks
In-vivo Wettability
Pre-lens non-invasive tear breakup time
Measured: 2 weeks
Subjective Comfort Rating
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
Measured: 2 weeks
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 startAug 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Desmond Fonn, M. Optom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520351
- Sponsor's protocol ID
- P/265/07/L
- Status last verified
- Aug 2010
- First submitted
- 21 Aug 2007
- Last updated
- 16 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
- ClinicalTrials.gov ID
- NCT00520351
- Acronym / sponsor ID
- P/265/07/L
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Posted 16 Sep 2010
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 the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Detailed description
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ClearCare |
| 2 | Active comparator | Drug: Optifree Replenish |
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 presently using either bi-weekly or monthly replacement lenses.
- Has symptoms of ocular dryness as determined by specific pre-screening criteria.
Key exclusion criteria (13 listed)
- Is an asymptomatic lens wearer.
- Is a daily disposable contact lens wearer.
- Is a current extended wear contact lens wearer.
- Currently uses one of the study lens care regimens.
- Has any clinically significant blepharitis.
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 |
|---|---|---|
| ClearCarecontact lens care system | Drug | 1 |
| Optifree Replenishcontact lens care system | Drug | 2 |
Primary outcome
High Contrast Visual Acuity
Time frame: 2 weeks
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Low Contrast Visual Acuity
Time frame: 2 weeks
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
In-vivo Wettability
Time frame: 2 weeks
Pre-lens non-invasive tear breakup time
Subjective Comfort Rating
Time frame: 2 weeks
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 ClearCare and Optifree Replenish in people with Myopia, 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 13 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 Sep 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 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?
Yes. Results are posted in the registry (first posted 16 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?
High Contrast Visual Acuity (time frame: 2 weeks). 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?
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 Sep 2010.