MyopiaNCT01583868
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
A study testing B&L RD2135-01 lens C, B&L RD2135-01 lens D and PureVision2 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 two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- B&L RD2135-01 lens C, B&L RD2135-01 lens D and PureVision2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2012
- 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
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
- Must agree to wear the study lenses on a daily wear basis for the duration of the study.
- Must be willing to use a lens care system on a regular basis.
- If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
Who cannot join
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Show all 15Show fewer
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Aphakic.
- Amblyopic.
- Allergic to any component in the study products.
- Have had any corneal surgery (ie, refractive surgery).
- Currently wear monovision correction, multifocal, or toric contact lenses.
- Ocular astigmatism greater than 1.00 D in either eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
- Conditions
- Myopia
- Being tested
- B&L RD2135-01 lens C, B&L RD2135-01 lens D, PureVision2, Air Optix Aqua
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B&L RD2135-01 lens CDevice
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
B&L RD2135-01 lens DDevice
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
PureVision2Device
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Air Optix AquaDevice
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
| Study group | Role | What they receive |
|---|---|---|
| B&L RD2135-01 lens C | Experimental | Investigational Silicone hydrogel soft contact lens Receives: Device: B&L RD2135-01 lens C |
| B&L RD2135-01 lens D | Experimental | Investigational Silicone hydrogel soft contact lens Receives: Device: B&L RD2135-01 lens D |
| PureVision2 | Active comparator | Bausch \& Lomb High definition soft contact lenses Receives: Device: PureVision2 |
| Ciba Vision Air Optix Aqua | Active comparator | Ciba Vision Air Optix Aqua soft contact lens Receives: Device: Air Optix Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Measured: At 1 week follow up
Secondary outcomes (1)
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.
Measured: At 1 Week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJul 2012
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly J Barna, CCRA, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583868
- Sponsor's protocol ID
- 755E
- Status last verified
- Sep 2020
- First submitted
- 23 Apr 2012
- Last updated
- 22 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT01583868
- Acronym / sponsor ID
- 755E
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 22 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 study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B&L RD2135-01 lens C | Experimental | Device: B&L RD2135-01 lens CInvestigational Silicone hydrogel soft contact lens |
| B&L RD2135-01 lens D | Experimental | Device: B&L RD2135-01 lens DInvestigational Silicone hydrogel soft contact lens |
| PureVision2 | Active comparator | Device: PureVision2Bausch \& Lomb High definition soft contact lenses |
| Ciba Vision Air Optix Aqua | Active comparator | Device: Air Optix AquaCiba Vision Air Optix Aqua soft contact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
- Must agree to wear the study lenses on a daily wear basis for the duration of the study.
Key exclusion criteria (15 listed)
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
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 |
|---|---|---|
| B&L RD2135-01 lens CLenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Device | B&L RD2135-01 lens C |
| B&L RD2135-01 lens DLenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Device | B&L RD2135-01 lens D |
| PureVision2Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Device | PureVision2 |
| Air Optix AquaLenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. | Device | Ciba Vision Air Optix Aqua |
Primary outcome
Visual Acuity
Time frame: At 1 week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
1 secondary outcome
Symptoms and Complaints
Time frame: At 1 Week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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 J Barna, CCRA 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 B&L RD2135-01 lens C, B&L RD2135-01 lens D and PureVision2 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 7 inclusion and 15 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 22 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 22 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?
Visual Acuity (time frame: At 1 week follow up). 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 22 Oct 2020.