MyopiaNCT02500368
A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
A study testing silicone hydrogel lens (test) in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- silicone hydrogel lens (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Sep 2015
- 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
- No healthy volunteers
- 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 and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
- Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)
Who cannot join
- -A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study
- Has any known active* ocular disease and/or infection
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
Show all 11Show fewer
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
- Is aphakic
- Has undergone corneal refractive surgery.
- For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
- For the purposes of this study, participants will be excluded, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.
Read the detailed description
The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).
- Conditions
- Myopia
- Being tested
- silicone hydrogel lens (test), enfilcon A lens (control)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone hydrogel lens (test)Device
contact lens
enfilcon A lens (control)Device
contact lens
| Study group | Role | What they receive |
|---|---|---|
| silicone hydrogel lens (test) | Experimental | Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. Receives: Device: silicone hydrogel lens (test) |
| enfilcon A lens (control) | Active comparator | Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. Receives: Device: enfilcon A lens (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Measured: Baseline and 1 week
Dryness
Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Measured: Baseline and 1 week
Secondary outcomes (20)
Lens Wettability
Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Measured: Baseline and 1 week
Surface Appearance
Grade ratings category (smooth, grainy, or other)
Measured: Baseline
Surface Appearance
Grade ratings category (smooth, grainy, or other)
Measured: 1 week
High Contrast Acuity at High Room Illumination
Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Measured: Baseline and 1 week
Lens Deposition
Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Measured: Baseline and 1 week
Lens Problems
Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Measured: Baseline and 1 week
Lens Centration
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Measured: Baseline
Lens Centration
Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Measured: 1 week
Post-blink Movement
Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)
Measured: Baseline and 1 week
Lens Tightness
Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Measured: Baseline and 1 week
Visual Quality
Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Measured: Baseline and 1 week
Ease of Lens Insertion
Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye
Measured: Baseline and 1 week
Ease of Lens Removal
Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.
Measured: 1 week
Overall Lens Fit
Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
- Poor (lens could be worn with supervision only);
- Fair (would prefer to refit, but clinically acceptable);
- Good (fit could be slightly improved);
- Very good (optimal)
Measured: Baseline and 1 week
Bulbar Hyperemia
Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Measured: Baseline and 1 week
Limbal Hyperemia
Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Measured: Baseline and 1 week
Corneal Dehydration Staining
Corneal Staining: Dehydration Staining: Yes/No
Measured: 1 week
Corneal Staining (Extent)
Corneal staining extent, grade as % of each zone:
C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Measured: Baseline and 1 week
Conjunctival Indentation
Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: Baseline and 1 week.
Conjunctival Staining
Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionSep 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD FCO, Principal investigator, Center for Contact Lens Research, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500368
- Sponsor's protocol ID
- CV-15-36
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2015
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
- ClinicalTrials.gov ID
- NCT02500368
- Acronym / sponsor ID
- CV-15-36
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.
Detailed description
The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone hydrogel lens (test) | Experimental | Device: silicone hydrogel lens (test)Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. |
| enfilcon A lens (control) | Active comparator | Device: enfilcon A lens (control)Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Is at least 17 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
- Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)
Key exclusion criteria (11 listed)
- Is participating in any concurrent clinical or research study
- Has any known active* ocular disease and/or infection
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
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 lens (test)contact lens | Device | silicone hydrogel lens (test) |
| enfilcon A lens (control)contact lens | Device | enfilcon A lens (control) |
Primary outcome
Comfort
Time frame: Baseline and 1 week
Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Dryness
Time frame: Baseline and 1 week
Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
20 secondary outcomes
Lens Wettability
Time frame: Baseline and 1 week
Surface Appearance
Time frame: Baseline
Surface Appearance
Time frame: 1 week
High Contrast Acuity at High Room Illumination
Time frame: Baseline and 1 week
Lens Deposition
Time frame: Baseline and 1 week
Lens Problems
Time frame: Baseline and 1 week
Lens Centration
Time frame: Baseline
Lens Centration
Time frame: 1 week
Post-blink Movement
Time frame: Baseline and 1 week
Lens Tightness
Time frame: Baseline and 1 week
Visual Quality
Time frame: Baseline and 1 week
Ease of Lens Insertion
Time frame: Baseline and 1 week
Ease of Lens Removal
Time frame: 1 week
Overall Lens Fit
Time frame: Baseline and 1 week
Bulbar Hyperemia
Time frame: Baseline and 1 week
Limbal Hyperemia
Time frame: Baseline and 1 week
Corneal Dehydration Staining
Time frame: 1 week
Corneal Staining (Extent)
Time frame: Baseline and 1 week
Conjunctival Indentation
Time frame: Baseline and 1 week.
Conjunctival Staining
Time frame: Baseline and 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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.
Lyndon Jones, PhD FCO principal investigator
Center for Contact Lens Research, 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 silicone hydrogel lens (test) in people with Myopia, run by CooperVision, Inc. 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 6 inclusion and 11 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 29 Jul 2020. 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 17 Feb 2017). 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: Baseline and 1 week). 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 29 Jul 2020.