Refractive ErrorsNCT03614130

Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

A study testing LID011121 contact lens and Comfilcon A contact lens in people with Refractive Errors, run by Alcon Research at 2 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 clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended 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?: LID011121 contact lens and Comfilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesUnited States
Study dates: 23 Aug 2018to 11 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 Institutional Review Board/Ethics Committee-approved Informed Consent form.
Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
Current Biofinity© lens wearer.
Pregnant or breast-feeding.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Alcon Investigative Site
Brentwood, Tennessee, 37027
Alcon Investigative Site
Johns Creek, Georgia, 30097

Other trials in United States

About this study

Official title: Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear

Read the detailed description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Conditions: Refractive Errors
Being tested: LID011121 contact lens, Comfilcon A contact lens
Keywords: Contact Lens, Extended Wear, Overnight Wear, Contralateral Wear, Vision Correction
Medical subject headings: Refractive Errors

What participants receive

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

LID011121 contact lensDevice
Investigational silicone hydrogel contact lens
Comfilcon A contact lensDevice
Also called Biofinity
Commercially available silicone hydrogel contact lens

Study groups in NCT03614130
Study group	Role	What they receive
LID011121 (OD) / Biofinity (OS)	Other	LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear Receives: Device: LID011121 contact lens; Device: Comfilcon A contact lens
Biofinity (OD) / LID011121 (OS)	Other	Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear Receives: Device: LID011121 contact lens; Device: Comfilcon A contact lens

What is being measured

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

Visual Acuity (VA) With Study Lenses, Collected by Eye
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Measured: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit

Timeline

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

23 Aug 201811 Sep 2018

First posted3 Aug 2018
Study start23 Aug 2018
Primary completion11 Sep 2018
Study completion11 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: Single group
Model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03614130
Sponsor's protocol ID: CLL949-C005
Status last verified: Sep 2021
First submitted: 30 Jul 2018
Last updated: 30 Sep 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

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
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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
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
Hyperopia and Myopia

All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear
ClinicalTrials.gov ID: NCT03614130
Acronym / sponsor ID: CLL949-C005
Conditions: Refractive Errors
Keywords: Contact Lens, Extended Wear, Overnight Wear, Contralateral Wear, Vision Correction
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 23 Aug 2018 (actual)
Primary completion: 11 Sep 2018 (actual)
Study completion: 11 Sep 2018 (actual)
First posted: 3 Aug 2018 (actual)
Results: Posted 30 Sep 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.

Arm	Type	Receives
LID011121 (OD) / Biofinity (OS)	Other	Device: LID011121 contact lens, Device: Comfilcon A contact lensLID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Biofinity (OD) / LID011121 (OS)	Other	Device: LID011121 contact lens, Device: Comfilcon A contact lensComfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear

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 Institutional Review Board/Ethics Committee-approved Informed Consent form.
Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (4 listed)

Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
Current Biofinity© lens wearer.
Pregnant or breast-feeding.
Other protocol-specified exclusion criteria may apply.

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
LID011121 contact lensInvestigational silicone hydrogel contact lens	Device	Biofinity (OD) / LID011121 (OS), LID011121 (OD) / Biofinity (OS)
Comfilcon A contact lensAlso: BiofinityCommercially available silicone hydrogel contact lens	Device	Biofinity (OD) / LID011121 (OS), LID011121 (OD) / Biofinity (OS)

Primary outcome

Visual Acuity (VA) With Study Lenses, Collected by Eye
Time frame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Results and safety

Results posted to the registry on 30 Sep 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
LID011121 (OD) / Biofinity (OS)	10	10
Biofinity (OD) / LID011121 (OS)	12	12

Primary outcome: Visual Acuity (VA) With Study Lenses, Collected by Eye

Time frame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit. Mean (Standard Deviation). Unit: logMAR

Measure	LID011121 n = 22	Biofinity n = 22
Day 1 Dispense	-0.04 (0.06)	-0.06 (0.06)
Day 2 Follow-up	-0.06 (0.11)	-0.09 (0.06)
Week 1 Follow-up/Exit	-0.06 (0.07)	-0.08 (0.06)

Population analysed: Safety Analysis Set

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 7 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 22 (0%)	0 of 22 (0%)	0 of 22
LID011121 - Ocular	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Biofinity - Ocular	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Nonocular/Systemic	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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
Astigmatism
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
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.

CDMA Project Lead, Vision Care study director

Alcon Research, LLC

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

Questions about this trial

What is this clinical trial studying?

A study testing LID011121 contact lens and Comfilcon A contact lens in people with Refractive Errors, run by Alcon Research at 2 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 4 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 Sep 2021. 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 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 30 Sep 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?

Visual Acuity (VA) With Study Lenses, Collected by Eye (time frame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit). 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 NCT03614130.

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 Sep 2021.