MyopiaNCT01309100
Product Feasibility of a New Silicone Hydrogel Contact Lens
A study testing Investigational Lens, Acuvue Oasys Lens and Air Optix Aqua 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 determine the clinical feasibility and to evaluate the product performance of investigational contact lens. 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 Lens, Acuvue Oasys Lens and Air Optix Aqua Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 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 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 myopic and require lens correction
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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
- Conditions
- Myopia
- Being tested
- Investigational Lens, Acuvue Oasys Lens, Air Optix Aqua 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 LensDevice
Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
Acuvue Oasys LensDevice
Johnson \& Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
Air Optix Aqua LensDevice
Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Lens | Experimental | Bausch \& Lomb investigational silicone hydrogel lens. Receives: Device: Investigational Lens |
| Acuvue Oasys Lens | Active comparator | Johnson \& Johnson Acuvue Oasys contact lens. Receives: Device: Acuvue Oasys Lens |
| Air Optix Aqua Lens | Active comparator | Ciba Vision Air Optix Aqua contact lens. Receives: Device: Air Optix Aqua Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (Investigational vs Air Optix Aqua Lens)
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Measured: 1 week
Visual Acuity (Investigational vs Acuvue Oasys Lens)
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
Measured: 1 week
Secondary outcomes (2)
Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Measured: 1 week
Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionJan 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tara Vaz, OD, Principal investigator, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309100
- Sponsor's protocol ID
- 672E
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2011
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
- ClinicalTrials.gov ID
- NCT01309100
- Acronym / sponsor ID
- 672E
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Posted 29 Apr 2014
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 determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Lens | Experimental | Device: Investigational LensBausch \& Lomb investigational silicone hydrogel lens. |
| Acuvue Oasys Lens | Active comparator | Device: Acuvue Oasys LensJohnson \& Johnson Acuvue Oasys contact lens. |
| Air Optix Aqua Lens | Active comparator | Device: Air Optix Aqua LensCiba Vision Air Optix Aqua contact lens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 myopic and require lens correction
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 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 |
|---|---|---|
| Investigational LensBausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week. | Device | Investigational Lens |
| Acuvue Oasys LensJohnson \& Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week. | Device | Acuvue Oasys Lens |
| Air Optix Aqua LensCiba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week. | Device | Air Optix Aqua Lens |
Primary outcome
Visual Acuity (Investigational vs Air Optix Aqua Lens)
Time frame: 1 week
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Visual Acuity (Investigational vs Acuvue Oasys Lens)
Time frame: 1 week
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
2 secondary outcomes
Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
Time frame: 1 week
Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- 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.
Tara Vaz, OD principal investigator
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 Lens, Acuvue Oasys Lens and Air Optix Aqua 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 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 29 Apr 2014. 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 29 Apr 2014). 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?
Visual Acuity (Investigational vs Air Optix Aqua Lens) (time frame: 1 week). 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 29 Apr 2014.