Contact Lens WearNCT03897712
A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
A study testing Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens and ReNu MultiPlus Lubricating and Rewetting Drops in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 7 sites in United States.
Trial summary
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens and ReNu MultiPlus Lubricating and Rewetting Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Feb 2019to 28 Aug 2019
- 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 able to read, understand, and provide written informed consent on the institutional review board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- Participants must have clear central corneas and be free of any anterior segment disorders in each eye.
- Participants must be myopic, require contact lens correction from -1.00 diopter (D) to -6.00 D, and wear contact lenses in each eye.
- Participants must be correctable through spherocylindrical refraction to 47 letters (0.0 logMAR) or better (distance, high-contrast) in each eye.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
- Participants must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
Who cannot join
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal), who are currently pregnant, plan to become pregnant during the study, or are breastfeeding.
- Participants who have worn gas permeable lenses in either eye within the last 30 days or who have worn polymethylmethacrylate lenses in either eye within the last 3 months.
- Participants with any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease in either eye or who are using any ocular medication.
Show all 21Show fewer
- Participants who currently wear monovision, multifocal, or toric contact lenses in either eye.
- Participants with an ocular astigmatism >1.00 D in either eye.
- Participants with anisometropia (spherical equivalent) >2.00 D.
- Participants with any Grade ≥2 finding in either eye during the slit lamp examination. Participants with corneal infiltrates in either eye, of any grade, are not eligible to participate in this study.
- Participants with any "present" finding during the slit lamp examination in either eye that, in the Investigator's judgment, interferes with contact lens wear.
- Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea in either eye. Note: participants 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 to participate in this study.
- Participants who are aphakic in either eye.
- Participants who are amblyopic in either eye.
- Participants who have had any corneal surgery (for example, refractive surgery) in either eye.
- Participants who are allergic to any component in the study care products.
- Participants who meet any of the following criteria:
- The participant is an employee of the investigative site.
- The participant, or a member of the participant's household, is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician.
- The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, or Johnson \& Johnson).
- The participant, or a member of the participant's household, is an employee of a market research firm.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Bausch Site 2
Denver, Colorado, 80246
Bausch Site 7
New Berlin, Wisconsin, 53151
Bausch Site 4
Pittsburg, Kansas, 66762
Bausch Site 1
San Francisco, California, 94112
Bausch Site 3
Sarasota, Florida, 34232
Bausch Site 6
Vestal, New York, 13850
Bausch Site 5
Warrensburg, Missouri, 64093
About this study
Official title: A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
- Conditions
- Contact Lens Wear
- Being tested
- Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens, ReNu MultiPlus Lubricating and Rewetting Drops, Biotrue Multi-Purpose Solution
- Keywords
- Soft Contact Lens, Soft Contact Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Samfilcon B Contact LensesDevice
Contact lens
Alden Optical HP Sphere Contact LensDevice
Also called Alden Optical® HP Sphere lens
Hioxifilcon D, 54% water, Alden Optical HP Sphere lens
ReNu MultiPlus Lubricating and Rewetting DropsDevice
Also called Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting Drops
For use as needed during the study.
Biotrue Multi-Purpose SolutionDevice
Also called Bausch + Lomb Biotrue® MPS
For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
| Study group | Role | What they receive |
|---|---|---|
| Custom Samfilcon B Contact Lenses | Experimental | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Receives: Device: Custom Samfilcon B Contact Lenses; Device: ReNu MultiPlus Lubricating and Rewetting Drops; Device: Biotrue Multi-Purpose Solution |
| Alden Optical HP Sphere contact lenses | Placebo comparator | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Receives: Device: Alden Optical HP Sphere Contact Lens; Device: ReNu MultiPlus Lubricating and Rewetting Drops; Device: Biotrue Multi-Purpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Distance High-contrast logMAR Lens VA
Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.
Measured: Month 3
Secondary outcomes (1)
Proportion Of Eyes With Grade >2 Slit Lamp Findings
Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) at any visit.
Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start27 Feb 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
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 Contact Lens WearStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897712
- Sponsor's protocol ID
- 886
- Status last verified
- Sep 2022
- First submitted
- 29 Mar 2019
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. 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 Custom Contact Lens
- ClinicalTrials.gov ID
- NCT03897712
- Acronym / sponsor ID
- 886
- Conditions
- Contact Lens Wear
- Keywords
- Soft Contact Lens, Soft Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 26 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom Samfilcon B Contact Lenses | Experimental | Device: Custom Samfilcon B Contact Lenses, Device: ReNu MultiPlus Lubricating and Rewetting Drops, Device: Biotrue Multi-Purpose SolutionParticipants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). |
| Alden Optical HP Sphere contact lenses | Placebo comparator | Device: Alden Optical HP Sphere Contact Lens, Device: ReNu MultiPlus Lubricating and Rewetting Drops, Device: Biotrue Multi-Purpose SolutionParticipants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be able to read, understand, and provide written informed consent on the institutional review board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- Participants must have clear central corneas and be free of any anterior segment disorders in each eye.
- Participants must be myopic, require contact lens correction from -1.00 diopter (D) to -6.00 D, and wear contact lenses in each eye.
- Participants must be correctable through spherocylindrical refraction to 47 letters (0.0 logMAR) or better (distance, high-contrast) in each eye.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
Key exclusion criteria (21 listed)
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal), who are currently pregnant, plan to become pregnant during the study, or are breastfeeding.
- Participants who have worn gas permeable lenses in either eye within the last 30 days or who have worn polymethylmethacrylate lenses in either eye within the last 3 months.
- Participants with any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
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 |
|---|---|---|
| Custom Samfilcon B Contact LensesContact lens | Device | Custom Samfilcon B Contact Lenses |
| Alden Optical HP Sphere Contact LensAlso: Alden Optical® HP Sphere lensHioxifilcon D, 54% water, Alden Optical HP Sphere lens | Device | Alden Optical HP Sphere contact lenses |
| ReNu MultiPlus Lubricating and Rewetting DropsAlso: Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting DropsFor use as needed during the study. | Device | Alden Optical HP Sphere contact lenses, Custom Samfilcon B Contact Lenses |
| Biotrue Multi-Purpose SolutionAlso: Bausch + Lomb Biotrue® MPSFor daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. | Device | Alden Optical HP Sphere contact lenses, Custom Samfilcon B Contact Lenses |
Primary outcome
Mean Distance High-contrast logMAR Lens VA
Time frame: Month 3
Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.
1 secondary outcome
Proportion Of Eyes With Grade >2 Slit Lamp Findings
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
Johnson Varughese study director
Bausch & Lomb Incorporated
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens and ReNu MultiPlus Lubricating and Rewetting Drops in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 7 sites 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 6 inclusion and 21 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 26 Oct 2022). 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?
Mean Distance High-contrast logMAR Lens VA (time frame: Month 3). 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 14 Nov 2022.