MyopiaNCT03351101

Clinical Study of Approved Contact Lenses

A study testing Senofilcon C and Samfilcon A in people with Myopia, run by Bausch & Lomb Incorporated at 11 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

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Senofilcon C and Samfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 271 participants
Where: 11 sitesUnited States
Study dates: 23 Oct 2017to 8 Dec 2017
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

Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).

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Subjects must be habitual wearers of Johnson \& Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
Subjects must use a contact lens care regimen on a routine basis.
Subjects must agree to wear their study lenses on a daily wear basis for the duration

Who cannot join

Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
she is currently pregnant
she plans to become pregnant during the study
she is breastfeeding
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Valeant Site 04
Denver, Colorado, 80246
Valeant Site 11
New Berlin, Wisconsin, 53151
Valeant Site 06
Orlando, Florida, 32803
Valeant Site 01
Orlando, Florida, 32812
Valeant Site 07
Pittsburg, Kansas, 66762
Valeant Site 10
Powell, Ohio, 43065
valeant Site 02
San Diego, California, 92123
Valeant Site 03
San Francisco, California, 94112
Valeant Site 05
Sarasota, Florida, 34232
Valeant Site 09
Vestal, New York, 13850
Valeant Site 08
Warrensburg, Missouri, 64093

Other trials in United States

About this study

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

Read the detailed description

to compare the performance of currently marketed Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.

Conditions: Myopia
Being tested: Senofilcon C, Samfilcon A
Medical subject headings: Myopia

What participants receive

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

Senofilcon CDevice
Senofilcon C Contact Lens
Samfilcon ADevice
Samfilcon A Contact Lens

Study groups in NCT03351101
Study group	Role	What they receive
Senofilcon C	Experimental	Senofilcon C Contact Lens Receives: Device: Senofilcon C
Samfilcon A	Experimental	Samfilcon A Contact Lens Receives: Device: Samfilcon A

What is being measured

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

End of Day Comfort
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.
Measured: 1 month
Overall Vision
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.
Measured: 1 month

Timeline

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

23 Oct 20178 Dec 2017

First posted22 Nov 2017
Study start23 Oct 2017
Primary completion10 Nov 2017
Study completion8 Dec 2017

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
Model description: randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03351101
Sponsor's protocol ID: ROC2-17-014
Status last verified: Jan 2021
First submitted: 9 Nov 2017
Last updated: 8 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

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 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Approved Contact Lenses
ClinicalTrials.gov ID: NCT03351101
Acronym / sponsor ID: ROC2-17-014
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 23 Oct 2017 (actual)
Primary completion: 10 Nov 2017 (actual)
Study completion: 8 Dec 2017 (actual)
First posted: 22 Nov 2017 (actual)
Results: Posted 16 Sep 2020

Clinical summary

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

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups

Arm	Type	Receives
Senofilcon C	Experimental	Device: Senofilcon CSenofilcon C Contact Lens
Samfilcon A	Experimental	Device: Samfilcon ASamfilcon A Contact Lens

Who may qualify

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

Key inclusion criteria (9 listed)

Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
Subjects must have clear central corneas and be free of any anterior segment disorders.

Key exclusion criteria (7 listed)

Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

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
Senofilcon CSenofilcon C Contact Lens	Device	Senofilcon C
Samfilcon ASamfilcon A Contact Lens	Device	Samfilcon A

Primary outcome

End of Day Comfort
Time frame: 1 month
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.
Overall Vision
Time frame: 1 month
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon C	136	135
Samfilcon A	132	129

Primary outcome: End of Day Comfort

Time frame: 1 month. Median (Standard Deviation). Unit: score on a scale

Measure	Senofilcon C n = 115	Samfilcon A n = 106
Value	80 (18.15)	80 (20.46)

Population analysed: All participants that completed all study visits without a major protocol deviation.

Primary outcome: Overall Vision

Time frame: 1 month. Median (Standard Deviation). Unit: score on a scale

Measure	Senofilcon C n = 115	Samfilcon A n = 106
Value	95 (9.68)	95 (12.15)

Population analysed: All participants that completed all study visits without a major protocol deviation.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon C	0 of 136 (0%)	0 of 136 (0%)	0 of 136
Samfilcon A	0 of 132 (0%)	1 of 132 (0.8%)	0 of 132

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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
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Myopia, Myopia Progressing
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
High Myopia, Intraocular Pressure
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Senofilcon C and Samfilcon A in people with Myopia, run by Bausch & Lomb Incorporated at 11 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 9 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 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 16 Sep 2020). 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?

End of Day Comfort (time frame: 1 month). The study lists 2 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 NCT03351101.

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 8 Jan 2021.