MyopiaNCT00784641
A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
A study testing Novel Bausch & Lomb daily disposable contact lenses, Bausch & Lomb SofLens daily disposable contact lenses. and Johnson and Johnson 1-Day Acuvue Moist contact lenses in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Evaluation of the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers… 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?
- Novel Bausch & Lomb daily disposable contact lenses, Bausch & Lomb SofLens daily disposable contact lenses. and Johnson and Johnson 1-Day Acuvue Moist contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2009
- 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 with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be myopic and require lens correction in both eyes.
Who cannot join
- Subjects with any systemic disease affecting ocular health.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects wearing monovision, multifocal or toric contact lenses.
- Subjects with grade 2 or greater slit lamp findings.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.
- Conditions
- Myopia
- Being tested
- Novel Bausch & Lomb daily disposable contact lenses, Bausch & Lomb SofLens daily disposable contact lenses., Johnson and Johnson 1-Day Acuvue Moist contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Bausch & Lomb daily disposable contact lensesDevice
Lenses to be worn and replaced daily for 2 weeks.
Bausch & Lomb SofLens daily disposable contact lenses.Device
Lenses to be worn and replaced daily for 2 weeks.
Johnson and Johnson 1-Day Acuvue Moist contact lensesDevice
Lenses to be worn and replaced daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Novel Bausch & Lomb Contact Lens | Experimental | Novel Bausch \& Lomb daily disposable contact lenses Receives: Device: Novel Bausch & Lomb daily disposable contact lenses |
| SofLens | Active comparator | Bausch \& Lomb SofLens daily disposable contact lenses Receives: Device: Bausch & Lomb SofLens daily disposable contact lenses. |
| Acuvue | Active comparator | Johnson and Johnson 1-Day Acuvue Moist contact lenses Receives: Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Measured: At dispensing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionJan 2009
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bev Barna, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784641
- Sponsor's protocol ID
- 496
- Status last verified
- Sep 2020
- First submitted
- 31 Oct 2008
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
- ClinicalTrials.gov ID
- NCT00784641
- Acronym / sponsor ID
- 496
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 6 Oct 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 the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novel Bausch & Lomb Contact Lens | Experimental | Device: Novel Bausch & Lomb daily disposable contact lensesNovel Bausch \& Lomb daily disposable contact lenses |
| SofLens | Active comparator | Device: Bausch & Lomb SofLens daily disposable contact lenses.Bausch \& Lomb SofLens daily disposable contact lenses |
| Acuvue | Active comparator | Device: Johnson and Johnson 1-Day Acuvue Moist contact lensesJohnson and Johnson 1-Day Acuvue Moist contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be myopic and require lens correction in both eyes.
Key exclusion criteria (4 listed)
- Subjects with any systemic disease affecting ocular health.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects wearing monovision, multifocal or toric contact lenses.
- Subjects with grade 2 or greater slit lamp findings.
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 |
|---|---|---|
| Novel Bausch & Lomb daily disposable contact lensesLenses to be worn and replaced daily for 2 weeks. | Device | Novel Bausch & Lomb Contact Lens |
| Bausch & Lomb SofLens daily disposable contact lenses.Lenses to be worn and replaced daily for 2 weeks. | Device | SofLens |
| Johnson and Johnson 1-Day Acuvue Moist contact lensesLenses to be worn and replaced daily for 2 weeks. | Device | Acuvue |
Primary outcome
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
Time frame: At dispensing
The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bev Barna study director
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 Novel Bausch & Lomb daily disposable contact lenses, Bausch & Lomb SofLens daily disposable contact lenses. and Johnson and Johnson 1-Day Acuvue Moist contact lenses 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 3 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 6 Oct 2020. 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 6 Oct 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?
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey (time frame: At dispensing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2020.