Contact Lens WearSILVERNCT01252134
Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
A study testing Biotrue multipurpose solution, Sauflon Synergi multipurpose solution and OTE Elements multipurpose solution in people with Contact Lens Wear, run by Alcon Research.
Trial summary
The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- Biotrue multipurpose solution, Sauflon Synergi multipurpose solution and OTE Elements multipurpose solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Soft contact lens wear on a daily wear basis
- Able to wear lenses at least 8 hours
- Generally healthy with normal ocular health
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Use of additional lens cleaners
- Known sensitivities to any ingredient in any of the study products
- History of ocular surgery/trauma within the last 6 months
- Other protocol-defined exclusion criteria may apply
About this study
Official title: The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.
- Conditions
- Contact Lens Wear
- Being tested
- Biotrue multipurpose solution, Sauflon Synergi multipurpose solution, OTE Elements multipurpose solution, Silicone hydrogel contact lenses (Acuvue Advance)
- Keywords
- Soft Contact lens, Multi-purpose solution, Wettability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotrue multipurpose solutionDevice
Contact lens care solution
Sauflon Synergi multipurpose solutionDevice
Contact lens care solution
OTE Elements multipurpose solutionDevice
Contact lens care solution
Silicone hydrogel contact lenses (Acuvue Advance)Device
Also called Acuvue® Advance™
Commercially marketed contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Synergi, then Biotrue, then OTE | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
| Synergi, then OTE, then Biotrue | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
| Biotrue, then OTE, then Synergi | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
| Biotrue, then Synergi, then OTE | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
| OTE, then Biotrue, then Synergi | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
| OTE, then Synergi, then Biotrue | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. Receives: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex Vivo Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
Measured: 8 hours
Secondary outcomes (3)
Subjective Comfort
Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.
Measured: 8 hours
Corneal Staining Type
Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.
Measured: 8 hours
Corneal Staining Extent
Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 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 Contact Lens WearStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252134
- Sponsor's protocol ID
- RDG10078 / SILVER
- Acronym
- SILVER
- Status last verified
- May 2012
- First submitted
- 1 Dec 2010
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
- ClinicalTrials.gov ID
- NCT01252134
- Acronym / sponsor ID
- SILVER / RDG10078 / SILVER
- Conditions
- Contact Lens Wear
- Keywords
- Soft Contact lens, Multi-purpose solution, Wettability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 11 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Synergi, then Biotrue, then OTE | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| Synergi, then OTE, then Biotrue | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| Biotrue, then OTE, then Synergi | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| Biotrue, then Synergi, then OTE | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| OTE, then Biotrue, then Synergi | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| OTE, then Synergi, then Biotrue | Other | Device: Biotrue multipurpose solution, Device: Sauflon Synergi multipurpose solution, Device: OTE Elements multipurpose solution, Device: Silicone hydrogel contact lenses (Acuvue Advance)Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age
- Soft contact lens wear on a daily wear basis
- Able to wear lenses at least 8 hours
- Generally healthy with normal ocular health
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (4 listed)
- Use of additional lens cleaners
- Known sensitivities to any ingredient in any of the study products
- History of ocular surgery/trauma within the last 6 months
- Other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| Biotrue multipurpose solutionContact lens care solution | Device | Biotrue, then OTE, then Synergi, Biotrue, then Synergi, then OTE, OTE, then Biotrue, then Synergi, OTE, then Synergi, then Biotrue, Synergi, then Biotrue, then OTE, Synergi, then OTE, then Biotrue |
| Sauflon Synergi multipurpose solutionContact lens care solution | Device | Biotrue, then OTE, then Synergi, Biotrue, then Synergi, then OTE, OTE, then Biotrue, then Synergi, OTE, then Synergi, then Biotrue, Synergi, then Biotrue, then OTE, Synergi, then OTE, then Biotrue |
| OTE Elements multipurpose solutionContact lens care solution | Device | Biotrue, then OTE, then Synergi, Biotrue, then Synergi, then OTE, OTE, then Biotrue, then Synergi, OTE, then Synergi, then Biotrue, Synergi, then Biotrue, then OTE, Synergi, then OTE, then Biotrue |
| Silicone hydrogel contact lenses (Acuvue Advance)Also: Acuvue® Advance™Commercially marketed contact lenses | Device | Biotrue, then OTE, then Synergi, Biotrue, then Synergi, then OTE, OTE, then Biotrue, then Synergi, OTE, then Synergi, then Biotrue, Synergi, then Biotrue, then OTE, Synergi, then OTE, then Biotrue |
Primary outcome
Ex Vivo Contact Angle
Time frame: 8 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
3 secondary outcomes
Subjective Comfort
Time frame: 8 hours
Corneal Staining Type
Time frame: 8 hours
Corneal Staining Extent
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biotrue multipurpose solution, Sauflon Synergi multipurpose solution and OTE Elements multipurpose solution in people with Contact Lens Wear, run by Alcon Research.
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 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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 11 Jun 2012). 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?
Ex Vivo Contact Angle (time frame: 8 hours). 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 11 Jun 2012.