Contact Lens CareNCT00382603
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients
A study testing OptiFree Multi-Purpose Disinfecting Solution in people with Contact Lens Care, run by Alcon Research at 1 site in United States.
Trial summary
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses. 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 Care
- What is being tested?
- OptiFree Multi-Purpose Disinfecting Solution
- Type of treatment
- Medical device
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2005
- Phase
- Interventional
- 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
Who may be able to join
- Symptomatic for contact lens related discomfort at the end of the lens wearing day.
- Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
- Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
- Successful lens wear for at least 4 hours per day.
- Vision correctable to 20/30.
- Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
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- No corneal surgery within the past 12 months.
- No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
- No over-the-counter or prescription ocular medication.
- No enrollment in another clinical study within 30 days prior to enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.
- Conditions
- Contact Lens Care
- Being tested
- OptiFree Multi-Purpose Disinfecting Solution
- Keywords
- Contact Lens Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiFree Multi-Purpose Disinfecting SolutionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events
Secondary outcomes (8)
Corneal Fluorescein Staining (Type and Area)
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Rewetting Drop Frequency
Lens Removal Frequency
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startAug 2004
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 362 participants
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Napier, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382603
- Sponsor's protocol ID
- C-04-09
- Status last verified
- Sep 2006
- First submitted
- 28 Sep 2006
- Last updated
- 16 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT00382603
- Acronym / sponsor ID
- C-04-09
- Conditions
- Contact Lens Care
- Keywords
- Contact Lens Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 29 Sep 2006 (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 objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Symptomatic for contact lens related discomfort at the end of the lens wearing day.
- Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
- Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
- Successful lens wear for at least 4 hours per day.
- Vision correctable to 20/30.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OptiFree Multi-Purpose Disinfecting Solution | Device | – |
Primary outcome
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events
8 secondary outcomes
Corneal Fluorescein Staining (Type and Area)
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Rewetting Drop Frequency
Lens Removal Frequency
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time
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 16 Aug 2012.
Related trials for Contact Lens Care
Enrolling by invitation
Smart Soft Contact Lenses for Monitoring Glaucoma
Glaucoma
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.
Leslie Napier study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiFree Multi-Purpose Disinfecting Solution in people with Contact Lens Care, 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 10 inclusion and 0 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 16 Aug 2012. 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?
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?
Efficacy:. The study lists 6 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 16 Aug 2012.