Refractive ErrorsNCT03459131

Clinical Evaluation of Two Monthly Contact Lenses

A study testing Comfilcon A with Digital Zone Optics™ contact lenses and Comfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Refractive Errors
What is being tested?: Comfilcon A with Digital Zone Optics™ contact lenses and Comfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2018to 26 Mar 2018
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 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Able to understand and sign an approved informed consent form (ICF);
Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
Refractive, ocular, or intraocular surgery, as specified in the protocol;
Current or history of eye injury or disorders, as specified in the protocol;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Use of topical ocular medications that would require instillation during contact lens wear;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Investigative Site
Maitland, Florida, 32751

Other trials in United States

About this study

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Conditions: Refractive Errors
Being tested: Comfilcon A with Digital Zone Optics™ contact lenses, Comfilcon A contact lenses
Medical subject headings: Refractive Errors

What participants receive

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

Comfilcon A with Digital Zone Optics™ contact lensesDevice
Also called BIOFINITY® ENERGYS™
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Comfilcon A contact lensesDevice
Also called BIOFINITY®
Silicone hydrogel spherical contact lenses

Study groups in NCT03459131
Study group	Role	What they receive
BIOFINITY ENERGYS then BIOFINITY	Other	Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. Receives: Device: Comfilcon A with Digital Zone Optics™ contact lenses; Device: Comfilcon A contact lenses
BIOFINITY then BIOFINITY ENERGYS	Other	Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. Receives: Device: Comfilcon A with Digital Zone Optics™ contact lenses; Device: Comfilcon A contact lenses

What is being measured

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

Subjective Rating of Overall Vision
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Measured: Day 7, each product

Secondary outcomes (1)

Over-refraction
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Measured: Day 1 (Dispense), each product

Timeline

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

7 Mar 201826 Mar 2018

First posted8 Mar 2018
Study start7 Mar 2018
Primary completion26 Mar 2018
Study completion26 Mar 2018

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 Refractive ErrorsStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03459131
Sponsor's protocol ID: CLD523-E001
Status last verified: Feb 2019
First submitted: 2 Mar 2018
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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 Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Two Monthly Contact Lenses
ClinicalTrials.gov ID: NCT03459131
Acronym / sponsor ID: CLD523-E001
Conditions: Refractive Errors
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 7 Mar 2018 (actual)
Primary completion: 26 Mar 2018 (actual)
Study completion: 26 Mar 2018 (actual)
First posted: 8 Mar 2018 (actual)
Results: Posted 5 Mar 2019

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 explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BIOFINITY ENERGYS then BIOFINITY	Other	Device: Comfilcon A with Digital Zone Optics™ contact lenses, Device: Comfilcon A contact lensesComfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
BIOFINITY then BIOFINITY ENERGYS	Other	Device: Comfilcon A with Digital Zone Optics™ contact lenses, Device: Comfilcon A contact lensesComfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Able to understand and sign an approved informed consent form (ICF);
Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;

Key exclusion criteria (8 listed)

Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
Refractive, ocular, or intraocular surgery, as specified in the protocol;
Current or history of eye injury or disorders, as specified in the protocol;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;

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
Comfilcon A with Digital Zone Optics™ contact lensesAlso: BIOFINITY® ENERGYS™Silicone hydrogel spherical contact lenses with Digital Zone Optics™	Device	BIOFINITY ENERGYS then BIOFINITY, BIOFINITY then BIOFINITY ENERGYS
Comfilcon A contact lensesAlso: BIOFINITY®Silicone hydrogel spherical contact lenses	Device	BIOFINITY ENERGYS then BIOFINITY, BIOFINITY then BIOFINITY ENERGYS

Primary outcome

Subjective Rating of Overall Vision
Time frame: Day 7, each product
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

1 secondary outcome

Over-refraction
Time frame: Day 1 (Dispense), each product

Results and safety

Results posted to the registry on 5 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIOFINITY ENERGYS Then BIOFINITY	7	7
BIOFINITY Then BIOFINITY ENERGYS	8	8

Primary outcome: Subjective Rating of Overall Vision

Time frame: Day 7, each product. Mean (Standard Deviation). Unit: units on a scale

Measure	BIOFINITY ENERGYS n = 15	BIOFINITY n = 15
Value	8.6 (1.2)	8.6 (1.1)

Population analysed: Safety Analysis Set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Dispense through study completion, an average of 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIOFINITY ENERGYS	0 of 15 (0%)	0 of 15 (0%)	0 of 15
BIOFINITY	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Errors

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
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RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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.

Alcon, A Novartis Division study director

Alcon, A Novartis Division

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

Questions about this trial

What is this clinical trial studying?

A study testing Comfilcon A with Digital Zone Optics™ contact lenses and Comfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 1 site in United States.

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 8 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 5 Mar 2019. 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 United States. 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 5 Mar 2019). 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?

Subjective Rating of Overall Vision (time frame: Day 7, each product). 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 NCT03459131.

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 5 Mar 2019.