MyopiaNCT01300065
Evaluation of Two Daily Disposable Contact Lenses.
A study testing Experimental- Soflens and Marketed - Soflens in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Experimental- Soflens and Marketed - Soflens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Subjects must be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
- Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.
Who cannot join
- Subjects 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.
- Subjects 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.
- 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 who are using any ocular medication.
- Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Show all 10Show fewer
- Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- Subjects who have had any corneal surgery (eg, refractive surgery).
- Subjects who are allergic to any component in the study care products.
- Subjects may not use their habitual rewetting drops while participating in this study.
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 Performance of Two Daily Disposable Contact Lenses
The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
- Conditions
- Myopia
- Being tested
- Experimental- Soflens, Marketed - Soflens
- Keywords
- 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.
Experimental- SoflensDevice
A new pair of lenses will be worn each day while the subject is in the study
Marketed - SoflensDevice
A new pair of lenses will be worn each day while the subject is in the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental- Soflens | Experimental | Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Receives: Device: Experimental- Soflens |
| Marketed - Soflens | Active comparator | Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Receives: Device: Marketed - Soflens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
Measured: 2 weeks
Secondary outcomes (1)
Initial Lens Performance Survey
A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.
Measured: At dispensing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMay 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 441 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
- NCT01300065
- Sponsor's protocol ID
- 642
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2011
- Last updated
- 6 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Performance of Two Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT01300065
- Acronym / sponsor ID
- 642
- Conditions
- Myopia
- Keywords
- contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Posted 6 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 clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental- Soflens | Experimental | Device: Experimental- SoflensBausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. |
| Marketed - Soflens | Active comparator | Device: Marketed - SoflensBausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Subjects must be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
Key exclusion criteria (10 listed)
- Subjects 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.
- Subjects 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.
- 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 who are using any ocular medication.
- 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 |
|---|---|---|
| Experimental- SoflensA new pair of lenses will be worn each day while the subject is in the study | Device | Experimental- Soflens |
| Marketed - SoflensA new pair of lenses will be worn each day while the subject is in the study. | Device | Marketed - Soflens |
Primary outcome
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Time frame: 2 weeks
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
1 secondary outcome
Initial Lens Performance Survey
Time frame: At dispensing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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 Experimental- Soflens and Marketed - Soflens 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 6 inclusion and 10 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 6 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 6 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?
Percentage of Eyes With > Grade 2 Slit Lamp Findings (time frame: 2 weeks). 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 6 Oct 2020.