MyopiaNCT01118338
Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses
A study testing Redesigned Purevision Contact Lens and PureVision Contact Lens in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Redesigned Purevision Contact Lens and PureVision Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of one of the listed contact lenses
- Subjects must be myopic
- Subjects must use a lens care system on a regular basis.
Who cannot join
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
- 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 with an active ocular disease or are using any ocular medication.
- 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 have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
- Conditions
- Myopia
- Being tested
- Redesigned Purevision Contact Lens, PureVision 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.
Redesigned Purevision Contact LensDevice
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
PureVision Contact LensDevice
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
| Study group | Role | What they receive |
|---|---|---|
| Redesigned Purevision Contact Lens | Experimental | Redesigned Bausch \& Lomb PureVision contact lens Receives: Device: Redesigned Purevision Contact Lens |
| PureVision Contact Lens | Active comparator | Bausch \& Lomb PureVision contact lens Receives: Device: PureVision Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
Measured: 1 month
Secondary outcomes (2)
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Measured: 1 month
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded 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). The outcome measure is any finding > grade 2, across abnormalities.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJul 2010
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Cairns, MCOptom, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118338
- Sponsor's protocol ID
- 648
- Status last verified
- Sep 2020
- First submitted
- 30 Apr 2010
- 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 Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
- ClinicalTrials.gov ID
- NCT01118338
- Acronym / sponsor ID
- 648
- Conditions
- Myopia
- Keywords
- contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 May 2010 (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.
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Redesigned Purevision Contact Lens | Experimental | Device: Redesigned Purevision Contact LensRedesigned Bausch \& Lomb PureVision contact lens |
| PureVision Contact Lens | Active comparator | Device: PureVision Contact LensBausch \& Lomb PureVision contact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of one of the listed contact lenses
- Subjects must be myopic
- Subjects must use a lens care system on a regular basis.
Key exclusion criteria (7 listed)
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
- 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 with an active ocular disease or are using any ocular medication.
- Subjects with 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 |
|---|---|---|
| Redesigned Purevision Contact LensLenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. | Device | Redesigned Purevision Contact Lens |
| PureVision Contact LensLenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. | Device | PureVision Contact Lens |
Primary outcome
Symptoms and Complaints
Time frame: 1 month
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
2 secondary outcomes
Visual Acuity
Time frame: 1 month
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Time frame: 1 month
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.
Gerard Cairns, MCOptom, PhD 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 Redesigned Purevision Contact Lens and PureVision 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 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 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?
Symptoms and Complaints (time frame: 1 month). 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.