Contact Lens WearNCT01069237
Compliance and Contamination in Soft Contact Lens Wearers
An observational study of Contact Lens Wear, run by Alcon Research.
Trial summary
The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- OPTI-FREE RepleniSH and Clear Care
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Contact Lens Wearers
Who may be able to join
- Successful contact lens wear on a daily wear basis
- Normal Eyes
Who cannot join
- Topical ocular medication use
- No active ocular issues
About this study
The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.
Read the detailed description
The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.
- Conditions
- Contact Lens Wear
- Being tested
- OPTI-FREE RepleniSH, Clear Care
- Keywords
- contact lens wear, multi-purpose solution, corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTI-FREE RepleniSHDevice
Multi-Purpose Solution for soft contact lenses
Clear CareDevice
Lens Care Solution for contact lenses
| Study group | Role | What they receive |
|---|---|---|
| OPTI-FREE Replenish | Multi-Purpose Solution for soft contact lenses Receives: Device: OPTI-FREE RepleniSH | |
| Clear Care | Lens Care Solution for contact lenses Receives: Device: Clear Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial colonization on soft contact lenses and lens cases associated with daily lens wear
Measured: 2 weeks
Secondary outcomes (1)
Regimen compliance
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jami Kern, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069237
- Sponsor's protocol ID
- SMA-09-45
- Status last verified
- Jan 2012
- First submitted
- 15 Feb 2010
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Contamination in Soft Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT01069237
- Acronym / sponsor ID
- SMA-09-45
- Conditions
- Contact Lens Wear
- Keywords
- contact lens wear, multi-purpose solution, corneal staining
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
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 the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.
Detailed description
The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTI-FREE Replenish | – | Device: OPTI-FREE RepleniSHMulti-Purpose Solution for soft contact lenses |
| Clear Care | – | Device: Clear CareLens Care Solution for contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Contact Lens Wearers
Key inclusion criteria (2 listed)
- Successful contact lens wear on a daily wear basis
- Normal Eyes
Key exclusion criteria (2 listed)
- Topical ocular medication use
- No active ocular issues
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 |
|---|---|---|
| OPTI-FREE RepleniSHMulti-Purpose Solution for soft contact lenses | Device | OPTI-FREE Replenish |
| Clear CareLens Care Solution for contact lenses | Device | Clear Care |
Primary outcome
Microbial colonization on soft contact lenses and lens cases associated with daily lens wear
Time frame: 2 weeks
1 secondary outcome
Regimen compliance
Time frame: Baseline, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Related trials for Contact Lens Wear
Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
Active, not recruiting
The A.R.R.E.S.T.® Contact Lens Study
Myopia, Myopia Progression
RecruitingPhase 4
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Dry Eye
Enrolling by invitation
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
Healthy Participants Study, Contact Lens Wear
Active, not recruiting
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
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.
Jami Kern study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 2 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 1 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbial colonization on soft contact lenses and lens cases associated with daily lens wear (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 1 Feb 2012.