MyopiaPhase 4NCT00349882
Effects of Contact Lens Care Regimens on the Corneal Epithelium
A Phase 4 study testing soft contact lens and Marketed multipurpose disinfection regimen in people with Myopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- soft contact lens and Marketed multipurpose disinfection regimen
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Is at least 18 years old 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 6/6 or better (each eye), with their habitual visual correction.
- Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).
- Has clear corneas and no active ocular disease.
Show all 14Show fewer
- Has had an ocular examination in the last 2 years.
- Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.
- An ineligible contact lens wearer is one who:
- Responds positively to points 1 to 7 above.
- Has a distance contact lens prescription between -0.50D and -9.00 D.
- Has astigmatism less than or equal to -1.00D cyl.
- Currently wears silicone hydrogel contact lenses successfully.
- Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.
Who cannot join
- 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.
Show all 14Show fewer
- Is pregnant or lactating.
- Is participating in any other type of clinical or research study.
- An ineligible contact lens wearer is one who:
- Responds positively to any of points 1 to 8 above for exclusion criteria.
- Has known sensitivity to the contact lens care solutions used in the study.
- Has ocular or systemic allergies that could adversely affect contact lens wear.
- 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 judgement makes contact lens wear inadvisable.
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
The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.
- Conditions
- Myopia
- Being tested
- soft contact lens, Marketed multipurpose disinfection regimen
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft contact lensDevice
Marketed multipurpose disinfection regimenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is to investigate the effects of two
different contact lens care solutions on the cornea.
Secondary outcomes (2)
The secondary outcome measure of this study is to compare the subjective and
objective responses between two different contact lens care solutions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Craig Woods, PhD, Principal investigator, University of WaterlooDesmond Fonn, MOptom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349882
- Sponsor's protocol ID
- P/216/05/L
- Status last verified
- Jul 2006
- First submitted
- 5 Jul 2006
- Last updated
- 10 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Contact Lens Care Regimens on the Corneal Epithelium
- ClinicalTrials.gov ID
- NCT00349882
- Acronym / sponsor ID
- P/216/05/L
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jun 2005
- First posted
- 10 Jul 2006 (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 compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is at least 18 years old 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 6/6 or better (each eye), with their habitual visual correction.
- Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).
Key exclusion criteria (14 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 |
|---|---|---|
| soft contact lens | Device | – |
| Marketed multipurpose disinfection regimen | Drug | – |
Primary outcome
The primary outcome measure of this study is to investigate the effects of two
different contact lens care solutions on the cornea.
2 secondary outcomes
The secondary outcome measure of this study is to compare the subjective and
objective responses between two different contact lens care solutions.
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 10 Jul 2006.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and 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.
Craig Woods, PhD principal investigator
University of Waterloo
Desmond Fonn, MOptom 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 4 study testing soft contact lens and Marketed multipurpose disinfection regimen 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 14 inclusion and 14 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 10 Jul 2006. 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?
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?
The primary outcome measure of this study is to investigate the effects of two. The study lists 2 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 10 Jul 2006.