AstigmatismNCT03681808

Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

A study testing Test in people with Astigmatism, run by Bausch & Lomb Incorporated at 13 sites in United States.

Completed

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

Trial summary

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: Test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 13 sitesUnited States
Study dates: 10 Oct 2018to 16 Dec 2019
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

Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Who cannot join

Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
Subject has systemic disease affecting ocular health.
Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Bausch Site 116
Bloomington, Illinois, 61701
Bausch Site 110
Brighton, New York, 14618
Bausch Site 105
Houston, Texas, 77204
Bausch Site 117
Irvine, California, 92618
Bausch Site 115
Issaquah, Washington, 98027
Bausch Site 102
Jacksonville, Florida, 32250
Bausch Site 118
New York, New York, 10022
Bausch Site 111
New York, New York, 10036
Bausch Site 114
Raleigh, North Carolina, 27603
Bausch Site 107
San Diego, California, 92123
Bausch Site 101
San Francisco, California, 94112
Bausch Site 108
San Jose, California, 95132
Bausch Site 104
Sunnyvale, California, 94087

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Read the detailed description

This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)

Conditions: Astigmatism
Being tested: Control, Test
Medical subject headings: Astigmatism

What participants receive

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

ControlDevice
Contact Lens
TestDevice
Soft Contact Lens

Study groups in NCT03681808
Study group	Role	What they receive
Test	Experimental	Soft Contact Lens Receives: Device: Test
Control	Active comparator	Contact lens Receives: Device: Control

What is being measured

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

Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Measured: Evaluated at the 1 week follow up visit

Timeline

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

10 Oct 201816 Dec 2019

First posted24 Sep 2018
Study start10 Oct 2018
Primary completion16 Dec 2019
Study completion16 Dec 2019

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 AstigmatismStudies 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: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Masking: Single blind
Who is masked: Investigator
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03681808
Sponsor's protocol ID: 885
Status last verified: Jan 2021
First submitted: 20 Sep 2018
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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism 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: A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
ClinicalTrials.gov ID: NCT03681808
Acronym / sponsor ID: 885
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 10 Oct 2018 (actual)
Primary completion: 16 Dec 2019 (actual)
Study completion: 16 Dec 2019 (actual)
First posted: 24 Sep 2018 (actual)
Results: Posted 17 Dec 2020

Clinical summary

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

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study

Arm	Type	Receives
Test	Experimental	Device: TestSoft Contact Lens
Control	Active comparator	Device: ControlContact lens

Who may qualify

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

Key inclusion criteria (4 listed)

Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Key exclusion criteria (5 listed)

Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
Subject has systemic disease affecting ocular health.
Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear

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
ControlContact Lens	Device	Control
TestSoft Contact Lens	Device	Test

Primary outcome

Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
Time frame: Evaluated at the 1 week follow up visit
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

Results and safety

Results posted to the registry on 17 Dec 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
Biotrue	123	109
Acuvue	119	102

Primary outcome: Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better

Time frame: Evaluated at the 1 week follow up visit. Count of participants. Unit: Participants

Measure	Biotrue n = 106	Acuvue n = 98
Value	105	92

Population analysed: The Per Protocol (PP) Population included all randomized participants without major protocol deviations who completed the study.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biotrue	0 of 123 (0%)	0 of 123 (0%)	0 of 123
Acuvue	0 of 119 (0%)	0 of 119 (0%)	0 of 119

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 Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Lindsey Mathew study director

Bausch Health Companies

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

Questions about this trial

What is this clinical trial studying?

A study testing Test in people with Astigmatism, run by Bausch & Lomb Incorporated at 13 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 5 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 13 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 17 Dec 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?

Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better (time frame: Evaluated at the 1 week follow up visit). 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 NCT03681808.

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.