MyopiaNCT00733291
Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)
A study testing Nelfilcon A contact lens, Etafilcon A contact lens and FID 107027 solution in people with Myopia, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Nelfilcon A contact lens, Etafilcon A contact lens and FID 107027 solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2008
- 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 or older.
- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
- Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- History of hypersensitivity to any components of the multi-purpose solution.
- Evidence or history of ocular conditions as prescribed in protocol.
- One functional eye or a monofit lens
- Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
- Significant corneal staining at visit 1 of each study period as prescribed in protocol.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.
Read the detailed description
Corneal staining and subjective responses for ocular redness and comfort will be compared.
- Conditions
- Myopia
- Being tested
- Nelfilcon A contact lens, Etafilcon A contact lens, FID 107027 solution
- Keywords
- Daily disposable contact lenses, Multi-purpose disinfecting solutions
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfilcon A contact lensDevice
Also called Focus Dailies with AquaRelease
Commercially marketed, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lensDevice
Also called 1-Day ACUVUE Moist
Commercially marketed, single vision, soft contact lens for daily disposable wear
FID 107027 solutionDevice
Also called Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Commercially marketed solution for contact lens disinfection
| Study group | Role | What they receive |
|---|---|---|
| Nelfilcon A soak / Nelfilcon A no-soak | Active comparator | Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. Receives: Device: Nelfilcon A contact lens; Device: FID 107027 solution |
| Nelfilcon A no soak / nelfilcon A soak | Active comparator | Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. Receives: Device: Nelfilcon A contact lens; Device: FID 107027 solution |
| Etafilcon A soak / etafilcon A no soak | Active comparator | Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. Receives: Device: Etafilcon A contact lens; Device: FID 107027 solution |
| Etafilcon A no soak / etafilcon A soak | Active comparator | Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. Receives: Device: Etafilcon A contact lens; Device: FID 107027 solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Corneal Staining Area
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.
Measured: After 2 hours of wear
Total Corneal Staining Type
Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.
Measured: After 2 hours of wear
Secondary outcomes (2)
Ocular Comfort
Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.
Measured: After 2 hours of wear
Ocular Redness
Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.
Measured: After two hours of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
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 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT00733291
- Sponsor's protocol ID
- MS-008
- Status last verified
- Dec 2011
- First submitted
- 11 Aug 2008
- Last updated
- 28 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)
- ClinicalTrials.gov ID
- NCT00733291
- Acronym / sponsor ID
- MS-008
- Conditions
- Myopia
- Keywords
- Daily disposable contact lenses, Multi-purpose disinfecting solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 21 Dec 2011
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 evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.
Detailed description
Corneal staining and subjective responses for ocular redness and comfort will be compared.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nelfilcon A soak / Nelfilcon A no-soak | Active comparator | Device: Nelfilcon A contact lens, Device: FID 107027 solutionNelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
| Nelfilcon A no soak / nelfilcon A soak | Active comparator | Device: Nelfilcon A contact lens, Device: FID 107027 solutionNelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
| Etafilcon A soak / etafilcon A no soak | Active comparator | Device: Etafilcon A contact lens, Device: FID 107027 solutionEtafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
| Etafilcon A no soak / etafilcon A soak | Active comparator | Device: Etafilcon A contact lens, Device: FID 107027 solutionEtafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
- Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- History of hypersensitivity to any components of the multi-purpose solution.
- Evidence or history of ocular conditions as prescribed in protocol.
- One functional eye or a monofit lens
- Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
- Significant corneal staining at visit 1 of each study period as prescribed in protocol.
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 |
|---|---|---|
| Nelfilcon A contact lensAlso: Focus Dailies with AquaReleaseCommercially marketed, single vision, soft contact lens for daily disposable wear | Device | Nelfilcon A no soak / nelfilcon A soak, Nelfilcon A soak / Nelfilcon A no-soak |
| Etafilcon A contact lensAlso: 1-Day ACUVUE MoistCommercially marketed, single vision, soft contact lens for daily disposable wear | Device | Etafilcon A no soak / etafilcon A soak, Etafilcon A soak / etafilcon A no soak |
| FID 107027 solutionAlso: Opti-Free RepleniSH Multi-Purpose Disinfecting SolutionCommercially marketed solution for contact lens disinfection | Device | Etafilcon A no soak / etafilcon A soak, Etafilcon A soak / etafilcon A no soak, Nelfilcon A no soak / nelfilcon A soak, Nelfilcon A soak / Nelfilcon A no-soak |
Primary outcome
Average Corneal Staining Area
Time frame: After 2 hours of wear
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.
Total Corneal Staining Type
Time frame: After 2 hours of wear
Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.
2 secondary outcomes
Ocular Comfort
Time frame: After 2 hours of wear
Ocular Redness
Time frame: After two hours of wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelfilcon A contact lens, Etafilcon A contact lens and FID 107027 solution in people with Myopia, run by Alcon Research 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 4 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 28 Dec 2011. 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 21 Dec 2011). 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?
Average Corneal Staining Area (time frame: After 2 hours of wear). 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 28 Dec 2011.