Refractive ErrorsNCT03586167

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

A study testing LID014341 contact lenses and Comfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 4 sites 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 assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Errors
What is being tested?: LID014341 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: 88 participants
Where: 4 sitesUnited States
Study dates: 1 Aug 2018to 27 Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and sign an informed consent form approved by an Institutional review board (IRB);
Successful wear of spherical monthly replacement soft 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;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Who cannot join

Any conditions or use of medications that could contraindicate contact lens wear;
History of or plan to have refractive surgery in either eye;
Irregular cornea in either eye;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
Wearing habitual contact lenses 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 and artificial tear or rewetting drops requiring instillation during contact lens wear;
Habitual Biofinity contact lens wearers.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Alcon Investigative Site
Bloomington, Illinois, 61701
Alcon Investigative Site
Johns Creek, Georgia, 30097
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111

Other trials in United States

About this study

The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Conditions: Refractive Errors
Being tested: LID014341 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.

LID014341 contact lensesDevice
Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
Comfilcon A contact lensesDevice
Also called BIOFINITY©
Silicone hydrogel contact lenses

Study groups in NCT03586167
Study group	Role	What they receive
LID014341	Experimental	LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis Receives: Device: LID014341 contact lenses
Biofinity	Active comparator	Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis Receives: Device: Comfilcon A contact lenses

What is being measured

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

Distance Visual Acuity (VA)
VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.
Measured: Day 30

Timeline

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

1 Aug 201827 Sep 2018

First posted13 Jul 2018
Study start1 Aug 2018
Primary completion27 Sep 2018
Study completion27 Sep 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03586167
Sponsor's protocol ID: CLY935-C004
Status last verified: Jun 2021
First submitted: 2 Jul 2018
Last updated: 30 Jun 2021
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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
ClinicalTrials.gov ID: NCT03586167
Acronym / sponsor ID: CLY935-C004
Conditions: Refractive Errors
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 1 Aug 2018 (actual)
Primary completion: 27 Sep 2018 (actual)
Study completion: 27 Sep 2018 (actual)
First posted: 13 Jul 2018 (actual)
Results: Posted 13 May 2021

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 assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
LID014341	Experimental	Device: LID014341 contact lensesLID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis
Biofinity	Active comparator	Device: Comfilcon A contact lensesComfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Able to understand and sign an informed consent form approved by an Institutional review board (IRB);
Successful wear of spherical monthly replacement soft 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;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Key exclusion criteria (8 listed)

Any conditions or use of medications that could contraindicate contact lens wear;
History of or plan to have refractive surgery in either eye;
Irregular cornea in either eye;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
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
LID014341 contact lensesInvestigational monthly replacement silicone hydrogel contact lenses with water gradient coating	Device	LID014341
Comfilcon A contact lensesAlso: BIOFINITY©Silicone hydrogel contact lenses	Device	Biofinity

Primary outcome

Distance Visual Acuity (VA)
Time frame: Day 30
VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.

Results and safety

Results posted to the registry on 13 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LID014341	58	57
Biofinity	28	28

Primary outcome: Distance Visual Acuity (VA)

Time frame: Day 30. Mean (Standard Deviation). Unit: logMAR

Measure	LID014341 n = 57	Biofinity n = 28
Value	-0.09 (0.07)	-0.09 (0.07)

Population analysed: Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response.

Adverse events

Time frame: Dispense through study completion, an average of 1 month (30 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LID014341	0 of 58 (0%)	0 of 58 (0%)	0 of 58
Biofinity	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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
Amblyopia
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 Research study director

Alcon Research

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

Questions about this trial

What is this clinical trial studying?

A study testing LID014341 contact lenses and Comfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 4 sites 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 4 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 13 May 2021). 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?

Distance Visual Acuity (VA) (time frame: Day 30). 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 NCT03586167.

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 Jun 2021.