MyopiaNCT01309867
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
A study testing Investigational Toric Lens and PureVision Toric Lens in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses. 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?
- Investigational Toric Lens and PureVision Toric Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- 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 lens wearers, 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
- Subjects must be habitual wearers of toric soft contact lenses.
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 an active ocular disease or who are using any ocular medication.
- 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 who are allergic to any component in the study care products.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
- Conditions
- Myopia
- Being tested
- Investigational Toric Lens, PureVision Toric Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Toric LensDevice
Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
PureVision Toric LensDevice
Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Toric Lens | Experimental | Bausch + Lomb investigational toric contact lenses Receives: Device: Investigational Toric Lens |
| PureVision Toric Lens | Active comparator | Currently marketed Bausch + Lomb PureVision toric contact lenses Receives: Device: PureVision Toric Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
Measured: 2 weeks
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Measured: 2 weeks
Secondary outcomes (2)
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.
Measured: 2 weeks
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: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionApr 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly Barna, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309867
- Sponsor's protocol ID
- 680
- Status last verified
- Oct 2020
- First submitted
- 4 Mar 2011
- Last updated
- 8 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
- ClinicalTrials.gov ID
- NCT01309867
- Acronym / sponsor ID
- 680
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Posted 8 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 the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Toric Lens | Experimental | Device: Investigational Toric LensBausch + Lomb investigational toric contact lenses |
| PureVision Toric Lens | Active comparator | Device: PureVision Toric LensCurrently marketed Bausch + Lomb PureVision toric contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 lens wearers, 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
- Subjects must be habitual wearers of toric soft contact lenses.
Key exclusion criteria (6 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 an active ocular disease or who are using any ocular medication.
- 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.
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 |
|---|---|---|
| Investigational Toric LensBausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. | Device | Investigational Toric Lens |
| PureVision Toric LensCurrently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. | Device | PureVision Toric Lens |
Primary outcome
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
Time frame: 2 weeks
Visual Acuity
Time frame: 2 weeks
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
2 secondary outcomes
Symptoms and Complaints
Time frame: 2 weeks
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Beverly 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 Investigational Toric Lens and PureVision Toric 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 6 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 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 8 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 Eyes With Absolute Lens Rotation ≤ 10 Degrees. (time frame: 2 weeks). 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?
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 Oct 2020.