MyopiaNCT05656885

Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

A study testing Lens A and Lens B in people with Myopia and Hyperopia, run by CooperVision, Inc. at 1 site in Spain.

Completed

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

Trial summary

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Lens A and Lens B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSpain
Study dates: 27 Sep 2022to 18 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 18 years of age and has full legal capacity to volunteer.
Has read and signed an information consent letter.
Self-reports having a full eye examination in the previous two years.
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
Is willing and able to follow instructions and maintain the appointment schedule.
Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
Has refractive astigmatism no higher than -0.75DC.
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Who cannot join

Is participating in any concurrent clinical or research study.
Has any known active ocular disease and/or infection that contraindicates contact lens wear.
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 contact lens wear or a study outcome variable.
Has known sensitivity to the diagnostic sodium fluorescein used in the study.
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
Has undergone refractive error surgery or intraocular surgery.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University Complutense of Madrid
Madrid, 28037

Other trials in Spain

About this study

Official title: Clinical Evaluation of Proclear Monthly and Avaira Vitality

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Read the detailed description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Conditions: Myopia, Hyperopia
Being tested: Lens A, Lens B
Medical subject headings: Myopia, Hyperopia

What participants receive

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

Lens ADevice
Soft spherical hydrogel contact lens for 15 minutes
Lens BDevice
Soft spherical silicone hydrogel contact lens for 15 minutes

Study groups in NCT05656885
Study group	Role	What they receive
Lens A	Experimental	All participants wore Lens A for 15 minutes (Period 1) Receives: Device: Lens A
Lens B	Experimental	All participants wore Lens B for 15 minutes (Period 2) Receives: Device: Lens B

What is being measured

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

Lens Fit Acceptance Rating
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.
Measured: 15 minutes

Timeline

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

27 Sep 202218 Oct 2022

First posted19 Dec 2022
Study start27 Sep 2022
Primary completion18 Oct 2022
Study completion18 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: Non-randomised
Intervention model: Crossover
Model description: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05656885
Sponsor's protocol ID: EX-MKTG-142
Status last verified: Dec 2022
First submitted: 2 Dec 2022
Last updated: 27 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Proclear Monthly and Avaira Vitality
ClinicalTrials.gov ID: NCT05656885
Acronym / sponsor ID: EX-MKTG-142
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 27 Sep 2022 (actual)
Primary completion: 18 Oct 2022 (actual)
Study completion: 18 Oct 2022 (actual)
First posted: 19 Dec 2022 (actual)
Results: Posted 27 Dec 2023

Clinical summary

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

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Detailed description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: All participants received Lens A and then Lens B in fixed-sequence order.

Arm	Type	Receives
Lens A	Experimental	Device: Lens AAll participants wore Lens A for 15 minutes (Period 1)
Lens B	Experimental	Device: Lens BAll participants wore Lens B for 15 minutes (Period 2)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Is at least 18 years of age and has full legal capacity to volunteer.
Has read and signed an information consent letter.
Self-reports having a full eye examination in the previous two years.
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
Is willing and able to follow instructions and maintain the appointment schedule.

Key exclusion criteria (7 listed)

Is participating in any concurrent clinical or research study.
Has any known active ocular disease and/or infection that contraindicates contact lens wear.
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 contact lens wear or a study outcome variable.
Has known sensitivity to the diagnostic sodium fluorescein 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
Lens ASoft spherical hydrogel contact lens for 15 minutes	Device	Lens A
Lens BSoft spherical silicone hydrogel contact lens for 15 minutes	Device	Lens B

Primary outcome

Lens Fit Acceptance Rating
Time frame: 15 minutes
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

Results and safety

Results posted to the registry on 27 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lens A (Hydrogel Contact Lens)	40	40
Lens B (Silicone Hydrogel Contact Lens)	0	0

Primary outcome: Lens Fit Acceptance Rating

Time frame: 15 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Lens A n = 40	Lens B n = 40
Value	3.28 (0.60)	3.48 (0.60)

Population analysed: All participants received Lens A and Lens B in sequential order.

Adverse events

Time frame: From dispense up to 15 minutes on each lens type, approximately 1.5 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Lens B	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Juan G Carracedo Rodríguez, OD,MSc,PhD principal investigator

University Complutense of Madrid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lens A and Lens B in people with Myopia and Hyperopia, run by CooperVision, Inc. at 1 site in Spain.

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 8 inclusion and 7 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 27 Dec 2023. 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 Spain. 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 27 Dec 2023). 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?

Lens Fit Acceptance Rating (time frame: 15 minutes). 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 NCT05656885.

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 27 Dec 2023.