MyopiaNCT01873846

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

A study testing Silicone Hydrogel 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

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Trial summary

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Myopia
What is being tested?: Silicone Hydrogel Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Jul 2013
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 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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 adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).

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Subjects must habitually wear soft contact lens.
Subject must have no active ocular disease or allergic conjunctivitis.
Subject must not be using any topical ocular medications.
Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Who cannot join

Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
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 an active ocular disease or who are using any ocular medication.
Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.

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Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
Subjects with any Grade 2 or greater finding during the slit lamp examination.
Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects with any scar or neovascularization within the central 4 mm of the cornea.
Subjects who are aphakic.
Subjects who are amblyopic.
Subjects who have had any corneal surgery (eg, refractive surgery).
Subjects who are allergic to any component in the study care products.
Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb Incorporated
Madison, New Jersey, 07940

Other trials in United States

About this study

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Conditions: Myopia
Being tested: Silicone Hydrogel 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.

Silicone Hydrogel Contact LensDevice

Study groups in NCT01873846
Study group	Role	What they receive
Silicone Hydrogel Contact Lens	Experimental	Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses. Receives: Device: Silicone Hydrogel Contact Lens

What is being measured

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

Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Measured: 7 days
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
Measured: 7 days
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses
Measured: 7 days

Secondary outcomes (2)

Lens Performance Assessment
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Measured: 2 weeks
Any Graded Slit Lamp Finding > 2
Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.
Measured: 2 weeks

Timeline

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

Apr 2013Jul 2013

First posted10 Jun 2013 (estimated)
Study startApr 2013
Primary completionMay 2013
Study completionJul 2013

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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01873846
Sponsor's protocol ID: 817
Status last verified: Jul 2019
First submitted: 28 May 2013
Last updated: 24 Jul 2019
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

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
ClinicalTrials.gov ID: NCT01873846
Acronym / sponsor ID: 817
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: May 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 10 Jun 2013 (estimated)
Results: Posted 24 Jul 2019

Clinical summary

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

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Silicone Hydrogel Contact Lens	Experimental	Device: Silicone Hydrogel Contact LensContact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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 adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.

Key exclusion criteria (17 listed)

Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
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 an active ocular disease or who are using any ocular medication.
Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.

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
Silicone Hydrogel Contact Lens	Device	Silicone Hydrogel Contact Lens

Primary outcome

Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Time frame: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Time frame: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Time frame: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses

2 secondary outcomes

Lens Performance Assessment
Time frame: 2 weeks
Any Graded Slit Lamp Finding > 2
Time frame: 2 weeks

Results and safety

Results posted to the registry on 24 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silicone Hydrogel Contact Lens	400	388

Primary outcome: Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Silicone Hydrogel Contact Lens n = 380
Prefer study lenses	195
Prefer usual lenses	93
About the same as usual lens	92

Population analysed: There were 380 eligible subjects with lenses dispensed.

Primary outcome: Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Silicone Hydrogel Contact Lens n = 380
Prefer study lenses	199
Prefer usual lenses	80
About the same as usual lens	101

Population analysed: There were 380 eligible subjects with lenses dispensed.

Primary outcome: Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Silicone Hydrogel Contact Lens n = 380
Prefer study lenses	162
Prefer usual lenses	51
About the same as usual lens	167

Population analysed: There were 380 eligible subjects with lenses dispensed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silicone Hydrogel Contact Lens	0 of 396 (0%)	0 of 396 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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.

Johnson Varughese study director

Valeant Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A study testing Silicone Hydrogel 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 11 inclusion and 17 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 24 Jul 2019. 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 24 Jul 2019). 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?

Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? (time frame: 7 days). The study lists 3 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 NCT01873846.

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 24 Jul 2019.