MyopiaNCT00658996
Product Performance of a Toric Contact Lens
A study testing SofLens DD Toric and Ciba Vision Focus Dailies Toric Contact Lens in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Malaysia.
Trial summary
Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- SofLens DD Toric and Ciba Vision Focus Dailies Toric Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2008to Jun 2008
- 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
- Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
- Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
- Clear central cornea
Who cannot join
- Systemic disease affecting ocular health
- Using systemic or topical medications
- Wears monovision or multifocal contact lenses
- Any grade 2 or greater slit lamp findings
- Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, 80400
About this study
Official title: A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
- Conditions
- Myopia, Astigmatism
- Being tested
- SofLens DD Toric, Ciba Vision Focus Dailies Toric Contact Lens
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofLens DD ToricDevice
daily disposable wear contact lens for 2 weeks
Ciba Vision Focus Dailies Toric Contact LensDevice
daily disposable wear contact lens for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| SofLens DD Toric | Experimental | Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens Receives: Device: SofLens DD Toric |
| Ciba Vision Toric Lens | Active comparator | Ciba Vision Focus Dailies Toric Contact Lens Receives: Device: Ciba Vision Focus Dailies Toric Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and Complaints
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Measured: Over-all follow-up visits for 2 week period
Contact Lens High Contrast Visual Acuity
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
Measured: Over-all follow-up visits, 2 weeks
Secondary outcomes (1)
Slit Lamp Findings
Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates
Measured: Over-all follow-up visits, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Cairns, PhD,MCOptom, Study director, Bausch & Lomb IncorporatedBenny Chian, MCOptom,DO, Principal investigator, Laser Focus Sdn Bhd, Vision Correction Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658996
- Sponsor's protocol ID
- 559
- Status last verified
- Dec 2011
- First submitted
- 12 Apr 2008
- Last updated
- 12 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
- ClinicalTrials.gov ID
- NCT00658996
- Acronym / sponsor ID
- 559
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 16 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SofLens DD Toric | Experimental | Device: SofLens DD ToricBausch \& Lomb SofLens Daily Disposable Toric Contact Lens |
| Ciba Vision Toric Lens | Active comparator | Device: Ciba Vision Focus Dailies Toric Contact LensCiba Vision Focus Dailies Toric Contact Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
- Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
- Clear central cornea
Key exclusion criteria (5 listed)
- Systemic disease affecting ocular health
- Using systemic or topical medications
- Wears monovision or multifocal contact lenses
- Any grade 2 or greater slit lamp findings
- Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
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 |
|---|---|---|
| SofLens DD Toricdaily disposable wear contact lens for 2 weeks | Device | SofLens DD Toric |
| Ciba Vision Focus Dailies Toric Contact Lensdaily disposable wear contact lens for 2 weeks | Device | Ciba Vision Toric Lens |
Primary outcome
Symptoms and Complaints
Time frame: Over-all follow-up visits for 2 week period
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Contact Lens High Contrast Visual Acuity
Time frame: Over-all follow-up visits, 2 weeks
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
1 secondary outcome
Slit Lamp Findings
Time frame: Over-all follow-up visits, 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- 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, PhD,MCOptom study director
Bausch & Lomb Incorporated
Benny Chian, MCOptom,DO principal investigator
Laser Focus Sdn Bhd, Vision Correction Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SofLens DD Toric and Ciba Vision Focus Dailies Toric Contact Lens in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Malaysia.
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 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 12 Dec 2011. 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 Malaysia. 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 16 Feb 2011). 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: Over-all follow-up visits for 2 week period). 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 12 Dec 2011.