MyopiaNCT01365039

Safety and Efficacy of a Contact Lens for Daily Disposable Use

A study testing Test, daily disposable contact lens and SofLens daily disposable contact lens in people with Myopia, run by Bausch & Lomb Incorporated 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

Search all trials

Trial summary

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia
What is being tested?: Test, daily disposable contact lens and SofLens daily disposable contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Oct 2011
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
Subjects must be free of any anterior segment disorders.
Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Who cannot join

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.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects who have had any corneal surgery (eg, refractive surgery).
Subjects who are allergic to any component in the study care products.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb, Inc.
Rochester, New York, 14609

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

Conditions: Myopia
Being tested: Test, daily disposable contact lens, SofLens daily disposable contact lens
Keywords: contact lens
Medical subject headings: Myopia

What participants receive

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

Test, daily disposable contact lensDevice
Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
SofLens daily disposable contact lensDevice
Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.

Study groups in NCT01365039
Study group	Role	What they receive
Test lens	Experimental	Test contact lens will be worn on a daily disposable wear basis. Receives: Device: Test, daily disposable contact lens
SofLens lens	Active comparator	The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. Receives: Device: SofLens daily disposable contact lens

What is being measured

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

Slit Lamp Findings > Grade 2
Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses
Measured: 4 visits over 3 months
High Contrast, Distance logMAR Visual Acuity (VA)
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
Measured: 4 visits over 3 months

Timeline

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

Jun 2011Oct 2011

First posted3 Jun 2011 (estimated)
Study startJun 2011
Primary completionOct 2011
Study completionOct 2011

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365039
Sponsor's protocol ID: 690
Status last verified: Nov 2013
First submitted: 1 Jun 2011
Last updated: 8 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
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
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
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
ClinicalTrials.gov ID: NCT01365039
Acronym / sponsor ID: 690
Conditions: Myopia
Keywords: contact lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 8 Jan 2014

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Test lens	Experimental	Device: Test, daily disposable contact lensTest contact lens will be worn on a daily disposable wear basis.
SofLens lens	Active comparator	Device: SofLens daily disposable contact lensThe currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
Subjects must be free of any anterior segment disorders.
Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Key exclusion criteria (5 listed)

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.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects who have had any corneal surgery (eg, refractive surgery).
Subjects who are allergic to any component in the study care 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
Test, daily disposable contact lensTest lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Device	Test lens
SofLens daily disposable contact lensControl lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Device	SofLens lens

Primary outcome

Slit Lamp Findings > Grade 2
Time frame: 4 visits over 3 months
Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses
High Contrast, Distance logMAR Visual Acuity (VA)
Time frame: 4 visits over 3 months
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint

Results and safety

Results posted to the registry on 8 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SofLens Lens	86	85
Test Lens	87	87

Primary outcome: Slit Lamp Findings > Grade 2

Time frame: 4 visits over 3 months. Number. Unit: eyes

Measure	SofLens Lens n = 86	Test Lens n = 87
Value	0	1

Population analysed: Over All Follow-up Visits, Eyes with Findings \> Grade 2 (All Dispensed Eyes)

Primary outcome: High Contrast, Distance logMAR Visual Acuity (VA)

Time frame: 4 visits over 3 months. Mean (Standard Deviation). Unit: logMAR

Measure	SofLens n = 86	Test Lens n = 87
Value	-0.028 (0.040)	-0.025 (0.040)

Population analysed: All Eligible, Dispensed Eyes

Adverse events

Time frame: 3 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SofLens Lens	0 of 86 (0%)	0 of 86 (0%)	Not reported
Test Lens	0 of 87 (0%)	0 of 87 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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
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
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.

Beverly Barna, CCRA principal investigator

Bausch & Lomb Incorporated

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

Questions about this trial

What is this clinical trial studying?

A study testing Test, daily disposable contact lens and SofLens daily disposable contact lens in people with Myopia, run by Bausch & Lomb Incorporated 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 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 2014. 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 8 Jan 2014). 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?

Slit Lamp Findings > Grade 2 (time frame: 4 visits over 3 months). 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 NCT01365039.

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 2014.