MyopiaNCT02939950
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
A study testing Bausch + Lomb Samfilcon A Soft Contact Lens and Bausch + Lomb Pure Vision Soft Contact Lens in people with Myopia, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Bausch + Lomb Samfilcon A Soft Contact Lens and Bausch + Lomb Pure Vision Soft Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2015to 3 Aug 2016
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
- Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
Who cannot join
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with an active ocular disease or who are using any ocular medication.
- Participants 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.
- Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
- Participants who currently wear monovision, multifocal, or toric contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis
The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
Read the detailed description
Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.
At the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.
- Conditions
- Myopia
- Being tested
- Bausch + Lomb Samfilcon A Soft Contact Lens, Bausch + Lomb Pure Vision Soft 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 Samfilcon A Soft Contact LensDevice
soft contact lenses
Bausch + Lomb Pure Vision Soft Contact LensDevice
soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | Experimental | Participants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. Receives: Device: Bausch + Lomb Samfilcon A Soft Contact Lens |
| Bausch + Lomb Pure Vision Soft Contact Lens | Active comparator | Participants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. Receives: Device: Bausch + Lomb Pure Vision Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Contrast Visual Acuity
For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).
Measured: Month 12
Number of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.
Measured: Baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start30 Apr 2015
- Primary completion3 Aug 2016
- Study completion3 Aug 2016
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.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939950
- Sponsor's protocol ID
- 818
- Status last verified
- Dec 2019
- First submitted
- 1 Jun 2015
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis
- ClinicalTrials.gov ID
- NCT02939950
- Acronym / sponsor ID
- 818
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 3 Aug 2016 (actual)
- Study completion
- 3 Aug 2016 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 10 Dec 2019
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 effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
Detailed description
Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.
At the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | Experimental | Device: Bausch + Lomb Samfilcon A Soft Contact LensParticipants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. |
| Bausch + Lomb Pure Vision Soft Contact Lens | Active comparator | Device: Bausch + Lomb Pure Vision Soft Contact LensParticipants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
- Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
Key exclusion criteria (6 listed)
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with an active ocular disease or who are using any ocular medication.
- Participants 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.
- Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
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 Samfilcon A Soft Contact Lenssoft contact lenses | Device | Bausch + Lomb Samfilcon A Soft Contact Lens |
| Bausch + Lomb Pure Vision Soft Contact Lenssoft contact lenses | Device | Bausch + Lomb Pure Vision Soft Contact Lens |
Primary outcome
High Contrast Visual Acuity
Time frame: Month 12
For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).
Number of Participants With Adverse Events
Time frame: Baseline up to Month 12
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Johnson Varughese study director
Bausch Health Americas, Inc.
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 Samfilcon A Soft Contact Lens and Bausch + Lomb Pure Vision Soft Contact Lens in people with Myopia, run by Bausch Health Americas, Inc. 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 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 23 Dec 2019. 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 2019). 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?
High Contrast Visual Acuity (time frame: Month 12). 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 23 Dec 2019.