MyopiaNCT04886479

Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

A study testing Test Lens in people with Myopia, run by CooperVision, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study. Read more about this study

Who is it for?: Ages 17 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Test Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesin 2 countries
Study dates: 6 Mar 2019to 7 Oct 2022
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 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.
Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 \& 2). This criterion is non-applicable to participants in group 3.

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Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.
GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.
GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.
For groups 1 \& 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group 3.
Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group 3.
Has clear and healthy corneas and anterior eye and no active ocular disease;
Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.
Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group 3.
Has a wearable pair of spectacles.

Who cannot join

Is participating in any concurrent clinical trial;
Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner
Has any known active ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study;

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Appears to have any active ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types;
Is aphakic;
Has undergone refractive error surgery, or has a history of any ocular surgery or injury.
Is a toric or multifocal contact lens wearer.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Canada1 site

CORE, University of Waterloo
Waterloo

Other trials in Canada

United Kingdom1 site

Eurolens Research
Manchester

Other trials in United Kingdom

About this study

Official title: Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers

This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

Read the detailed description

The purpose of this study was to to compare physiological response baseline data between 3 groups - habitual wearers of Daily Disposable Silicone Hydrogel (DDSH) contact lenses, habitual wearers of Daily Disposable Hydrogel (DDH) contact lenses, and non-lens wearers. The study then compared physiological response data following wear of a low Dk HEMA contact lens between habitual wearers of DDSH and habitual wearers of DDH.

Conditions: Myopia
Being tested: Control, Test Lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ControlOther
No lens
Test LensDevice
Low Dk HEMA contact lens worn for 3 hours

Study groups in NCT04886479
Study group	Role	What they receive
Daily Disposable Silicone Hydrogel Contact Lens Wearers	Experimental	Participants wore Test Lens for 3 hours Receives: Device: Test Lens
Daily Disposable Hydrogel Contact Lens Wearers	Experimental	Participants wore Test Lens for 3 hours Receives: Device: Test Lens
Non-lens Wearers	Active comparator	Participants did not receive Test Lens Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Limbal Redness - DDSH, DDH, Non-lens Groups
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Measured: 6-8 hours of habitual wear
Bulbar Redness DDSH, DDH, Non-lens Groups
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Measured: 6-8 hours of habitual wear
Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups
Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.
Measured: 6-8 hours of habitual wear
Limbal Redness - DDSH, DDH Groups
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Measured: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
Bulbar Redness - DDSH, DDH Groups
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Measured: Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal

Secondary outcomes (1)

Central Corneal Swelling (%) - DDSH, DDH Groups
Difference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness.
Measured: Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 20197 Oct 2022

First posted14 May 2021
Study start6 Mar 2019
Primary completion7 Oct 2022
Study completion7 Oct 2022

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: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04886479
Sponsor's protocol ID: EX-MKTG-89
Status last verified: Nov 2023
First submitted: 10 May 2021
Last updated: 30 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers
ClinicalTrials.gov ID: NCT04886479
Acronym / sponsor ID: EX-MKTG-89
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 6 Mar 2019 (actual)
Primary completion: 7 Oct 2022 (actual)
Study completion: 7 Oct 2022 (actual)
First posted: 14 May 2021 (actual)
Results: Posted 30 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Daily Disposable Silicone Hydrogel Contact Lens Wearers	Experimental	Device: Test LensParticipants wore Test Lens for 3 hours
Daily Disposable Hydrogel Contact Lens Wearers	Experimental	Device: Test LensParticipants wore Test Lens for 3 hours
Non-lens Wearers	Active comparator	Other: ControlParticipants did not receive Test Lens

Who may qualify

Ages: 17 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (15 listed)

Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.

Key exclusion criteria (12 listed)

Is participating in any concurrent clinical trial;
Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner
Has any known active ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;

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
ControlNo lens	Other	Non-lens Wearers
Test LensLow Dk HEMA contact lens worn for 3 hours	Device	Daily Disposable Hydrogel Contact Lens Wearers, Daily Disposable Silicone Hydrogel Contact Lens Wearers

Primary outcome

Limbal Redness - DDSH, DDH, Non-lens Groups
Time frame: 6-8 hours of habitual wear
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Bulbar Redness DDSH, DDH, Non-lens Groups
Time frame: 6-8 hours of habitual wear
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups
Time frame: 6-8 hours of habitual wear
Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.
Limbal Redness - DDSH, DDH Groups
Time frame: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Bulbar Redness - DDSH, DDH Groups
Time frame: Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.

1 secondary outcome

Central Corneal Swelling (%) - DDSH, DDH Groups
Time frame: Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal

Results and safety

Results posted to the registry on 30 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DDSH Lens Wearers	10	10
DDH Lens Wearers	3	3
Non-lens Wearers	9	9

Primary outcome: Limbal Redness - DDSH, DDH, Non-lens Groups

Time frame: 6-8 hours of habitual wear. Mean (95% Confidence Interval). Unit: score on a scale

Measure	DDSH Lens Wearers n = 10	DDH Lens Wearers n = 3	Non-lens Wearers n = 9
OD, T	0.41 (0.24 to 0.58)	0.37 (0.05 to 0.68)	0.44 (0.26 to 0.63)
OD, N	0.49 (0.25 to 0.73)	0.40 (-0.04 to 0.84)	0.44 (0.19 to 0.70)
OS, T	0.54 (0.35 to 0.73)	0.30 (-0.05 to 0.65)	0.46 (0.25 to 0.66)
OS, N	0.32 (0.18 to 0.46)	0.37 (0.12 to 0.62)	0.41 (0.27 to 0.56)

Primary outcome: Bulbar Redness DDSH, DDH, Non-lens Groups

Time frame: 6-8 hours of habitual wear. Mean (95% Confidence Interval). Unit: score on a scale

Measure	DDSH Lens Wearers n = 10	DDH Lens Wearers n = 3	Non-lens Wearers n = 9
OD, T	0.76 (0.55 to 0.97)	0.67 (0.28 to 1.05)	0.79 (0.56 to 1.01)
OD, N	0.86 (0.59 to 1.13)	0.83 (0.33 to 1.33)	0.71 (0.42 to 1.00)
OS, T	0.93 (0.63 to 1.23)	0.73 (0.18 to 1.28)	0.80 (0.48 to 1.12)
OS, N	0.86 (0.60 to 1.12)	0.60 (0.13 to 1.07)	0.67 (0.40 to 0.94)

Primary outcome: Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups

Time frame: 6-8 hours of habitual wear. Count of participants. Unit: Participants

Measure	DDSH Lens Wearers n = 10	DDH Lens Wearers n = 3	Non-lens Wearers n = 9
Value	2	2	0

Primary outcome: Limbal Redness - DDSH, DDH Groups

Time frame: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal. Mean (95% Confidence Interval). Unit: score on a scale

Measure	DDSH Lens Wearers n = 10	DDH Lens Wearers n = 3
T, t=baseline	0.48 (0.28 to 0.68)	0.33 (-0.04 to 0.71)
T, t=0 hour	0.70 (0.50 to 0.90)	0.43 (0.07 to 0.79)
T, t=1 hours	0.61 (0.36 to 0.86)	0.43 (-0.03 to 0.90)
T, t=3 hours	0.71 (0.45 to 0.97)	0.30 (-0.17 to 0.77)
N, t=baseline	0.36 (0.16 to 0.56)	0.50 (0.13 to 0.87)
N, t=0 hour	0.72 (0.44 to 1.00)	0.63 (0.11 to 1.15)
N, t=1 hours	0.57 (0.33 to 0.81)	0.57 (0.13 to 1.01)
N, t=3 hours	0.63 (0.34 to 0.92)	0.43 (-0.10 to 0.97)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study exit, up to 30 days from the first visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DDSH Lens Wearers	0 of 10 (0%)	0 of 10 (0%)	0 of 10
DDH Lens Wearers	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Non-lens Wearers	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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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 FCOptom principal investigator

Centre for Ocular Research & Education

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens in people with Myopia, run by CooperVision, Inc. at 2 sites in 2 countries.

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 15 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 30 Jan 2024. 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 Canada, 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?

Yes. Results are posted in the registry (first posted 30 Jan 2024). 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?

Limbal Redness - DDSH, DDH, Non-lens Groups (time frame: 6-8 hours of habitual wear). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04886479.

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 30 Jan 2024.