MyopiaNCT03384628
An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
A study testing First pair Senofilcon A contact lens, Second pair Senofilcon A contact lens and Third pair Senofilcon A contact lens in people with Myopia, run by Graeme Young at 2 sites in United Kingdom.
Trial summary
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- First pair Senofilcon A contact lens, Second pair Senofilcon A contact lens and Third pair Senofilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Jan 2018to 24 May 2018
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years.
- Able to read, comprehend and sign an informed consent.
- Willing to comply with the wear and study assessment schedule.
- Spherical distance prescription between -0.50 and -6.00 (inc.).
- Astigmatism, if present,≤1.50DC in both eyes.
- Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).
Who cannot join
- Previous anterior ocular surgery
- Any active corneal infection, injury or inflammation
- . •Large pinguecula likely to affect soft lens fit
- Systemic or ocular disease or medication which might interfere with CL wear
- Pregnancy or breastfeeding
- Participation in any concurrent trial
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Aston University Optometry Clinic
Birmingham, West Midlands, B4 7ET
Visioncare research
Farnham, Surrey, GU9 7EN
About this study
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.
Read the detailed description
This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).
- Conditions
- Myopia
- Being tested
- First pair Senofilcon A contact lens, Second pair Senofilcon A contact lens, Third pair Senofilcon A contact lens
- Keywords
- Contact lens, The Young Theory
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First pair Senofilcon A contact lensDevice
Fit assessment of the first pair contact lenses.
Second pair Senofilcon A contact lensDevice
Fit assessment of the second pair of contact lenses.
Third pair Senofilcon A contact lensDevice
Fit assessment of the third pair of contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| First Pair Senofilcon A contact lens | Active comparator | The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal. Receives: Device: First pair Senofilcon A contact lens |
| Second pair Senofilcon A contact lens | Active comparator | The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal. Receives: Device: Second pair Senofilcon A contact lens |
| Third pair Senofilcon A contact lens | Active comparator | The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal. Receives: Device: Third pair Senofilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens fit (position on the eye) in mm
Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm),
Measured: 25 minutes
Lens edge tightness fit grade 0-4
Edge tightness (grade 0-4)
Measured: 5 minutes
Lens tightness fit graded as %
Tightness (push-up %),
Measured: 5 minutes
Lens overall fit grade 0-5
Overall fit acceptability (Grade 0-5),
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start26 Jan 2018
- Primary completion24 May 2018
- Study completion24 May 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each subject will wear the three contact lens types bilaterally in random succession
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graeme Young
- Sponsor type
- University, hospital or other
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor-investigator, Graeme Young, Visioncare Research Ltd.
- Investigators
- Graeme Young, PhD MPhil, Study director, Managing director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384628
- Sponsor's protocol ID
- TRTN-501
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
- ClinicalTrials.gov ID
- NCT03384628
- Acronym / sponsor ID
- TRTN-501
- Conditions
- Myopia
- Keywords
- Contact lens, The Young Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Graeme YoungUniversity, hospital or other
- Collaborators
- Visioncare Research Ltd.
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 27 Dec 2017 (actual)
- 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.
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.
Detailed description
This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each subject will wear the three contact lens types bilaterally in random succession
| Arm | Type | Receives |
|---|---|---|
| First Pair Senofilcon A contact lens | Active comparator | Device: First pair Senofilcon A contact lensThe first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal. |
| Second pair Senofilcon A contact lens | Active comparator | Device: Second pair Senofilcon A contact lensThe second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal. |
| Third pair Senofilcon A contact lens | Active comparator | Device: Third pair Senofilcon A contact lensThe third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years.
- Able to read, comprehend and sign an informed consent.
- Willing to comply with the wear and study assessment schedule.
- Spherical distance prescription between -0.50 and -6.00 (inc.).
- Astigmatism, if present,≤1.50DC in both eyes.
Key exclusion criteria (6 listed)
- Previous anterior ocular surgery
- Any active corneal infection, injury or inflammation
- . •Large pinguecula likely to affect soft lens fit
- Systemic or ocular disease or medication which might interfere with CL wear
- Pregnancy or breastfeeding
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 |
|---|---|---|
| First pair Senofilcon A contact lensFit assessment of the first pair contact lenses. | Device | First Pair Senofilcon A contact lens |
| Second pair Senofilcon A contact lensFit assessment of the second pair of contact lenses. | Device | Second pair Senofilcon A contact lens |
| Third pair Senofilcon A contact lensFit assessment of the third pair of contact lenses. | Device | Third pair Senofilcon A contact lens |
Primary outcome
Lens fit (position on the eye) in mm
Time frame: 25 minutes
Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm),
Lens edge tightness fit grade 0-4
Time frame: 5 minutes
Edge tightness (grade 0-4)
Lens tightness fit graded as %
Time frame: 5 minutes
Tightness (push-up %),
Lens overall fit grade 0-5
Time frame: 5 minutes
Overall fit acceptability (Grade 0-5),
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 7 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Graeme Young, PhD MPhil study director
Managing director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First pair Senofilcon A contact lens, Second pair Senofilcon A contact lens and Third pair Senofilcon A contact lens in people with Myopia, run by Graeme Young at 2 sites in United Kingdom.
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 7 inclusion and 6 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
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?
Lens fit (position on the eye) in mm (time frame: 25 minutes). 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 7 Jun 2018.