MyopiaNCT01130974
A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
A study testing Bausch & Lomb contact lens and Marketed daily disposable contact lens in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Bausch & Lomb contact lens and Marketed daily disposable contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 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 soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Subjects must be of Asian descent.
- Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.
Who cannot join
- Subjects who have 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 with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- Subjects who currently wear monovision, multifocal, or toric contact lenses.
- Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).
- Conditions
- Myopia
- Being tested
- Bausch & Lomb contact lens, Marketed daily disposable 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.
Bausch & Lomb contact lensDevice
Bausch \& Lomb daily disposable cosmetic tint contact lens
Marketed daily disposable contact lensDevice
Marketed daily disposable cosmetic tint contact lens
| Study group | Role | What they receive |
|---|---|---|
| Bausch & Lomb contact lens | Experimental | Bausch \& Lomb daily disposable cosmetic tint contact lens Receives: Device: Bausch & Lomb contact lens |
| Marketed daily disposable contact lens | Active comparator | Marketed daily disposable cosmetic tint contact lens Receives: Device: Marketed daily disposable contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings
Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
Measured: Summarized over all follow-up visits through 1 month
logMAR Visual Acuity (VA)
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Measured: Summarized over all visits, and dispensed visit
logMAR Visual Acuity (VA)
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Measured: 2 week and 1 month follow-up
Secondary outcomes (5)
Lens Wettability
Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Measured: Summarized over all follow-up visits through 1 month
Lens Deposits
Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month
Measured: Summarized over all follow-up visits through one month
Lens Centration
Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).
Suboptimal lens centration was defined as a rating other than excellent.
Measured: Summarized over all follow-up visits through 1 month
Lens Movement
Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.
Measured: Summarized over all follow-up visits through one month
Symptoms & Complaints
Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.
Measured: Summarized over all follow-up visits through one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionSep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT01130974
- Sponsor's protocol ID
- 639
- Status last verified
- Nov 2013
- First submitted
- 25 May 2010
- Last updated
- 10 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
- ClinicalTrials.gov ID
- NCT01130974
- Acronym / sponsor ID
- 639
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 10 Dec 2013
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 safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bausch & Lomb contact lens | Experimental | Device: Bausch & Lomb contact lensBausch \& Lomb daily disposable cosmetic tint contact lens |
| Marketed daily disposable contact lens | Active comparator | Device: Marketed daily disposable contact lensMarketed daily disposable cosmetic tint contact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Subjects must be of Asian descent.
- Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.
Key exclusion criteria (7 listed)
- Subjects who have 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 with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
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 |
|---|---|---|
| Bausch & Lomb contact lensBausch \& Lomb daily disposable cosmetic tint contact lens | Device | Bausch & Lomb contact lens |
| Marketed daily disposable contact lensMarketed daily disposable cosmetic tint contact lens | Device | Marketed daily disposable contact lens |
Primary outcome
Slit Lamp Findings
Time frame: Summarized over all follow-up visits through 1 month
Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
logMAR Visual Acuity (VA)
Time frame: Summarized over all visits, and dispensed visit
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
logMAR Visual Acuity (VA)
Time frame: 2 week and 1 month follow-up
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
5 secondary outcomes
Lens Wettability
Time frame: Summarized over all follow-up visits through 1 month
Lens Deposits
Time frame: Summarized over all follow-up visits through one month
Lens Centration
Time frame: Summarized over all follow-up visits through 1 month
Lens Movement
Time frame: Summarized over all follow-up visits through one month
Symptoms & Complaints
Time frame: Summarized over all follow-up visits through one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- 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 Bausch & Lomb contact lens and Marketed daily disposable 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 5 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 10 Dec 2013. 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 10 Dec 2013). 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?
Slit Lamp Findings (time frame: Summarized over all follow-up visits through 1 month). 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?
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 10 Dec 2013.