Contact Lens CareNCT00407238
Corneal Barrier Function With Multi-Purpose Solutions
A study testing Multi-purpose solutions (polyquaternium-1 and PHMB) in people with Contact Lens Care, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use. 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?
- Multi-purpose solutions (polyquaternium-1 and PHMB)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2007
- 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
- Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40
Who cannot join
- Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry
Fullerton, California, 92831
About this study
Official title: Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.
Read the detailed description
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.
- Conditions
- Contact Lens Care
- Being tested
- Multi-purpose solutions (polyquaternium-1 and PHMB)
- Keywords
- barrier function, multi-purpose solutions, silicone hydrogel contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-purpose solutions (polyquaternium-1 and PHMB)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of fluorescein dye penetration rate of test eye vs. control
Secondary outcomes (1)
Corneal fluorescein staining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Study completionMar 2007
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.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Jerry R Paugh, OD, PhD, Principal investigator, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407238
- Sponsor's protocol ID
- 6-08
- Status last verified
- Oct 2007
- First submitted
- 17 Nov 2006
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions
- ClinicalTrials.gov ID
- NCT00407238
- Acronym / sponsor ID
- 6-08
- Conditions
- Contact Lens Care
- Keywords
- barrier function, multi-purpose solutions, silicone hydrogel contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Nov 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 4 Dec 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 purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.
Detailed description
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40
Key exclusion criteria (1 listed)
- Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications
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 |
|---|---|---|
| Multi-purpose solutions (polyquaternium-1 and PHMB) | Device | – |
Primary outcome
Ratio of fluorescein dye penetration rate of test eye vs. control
1 secondary outcome
Corneal fluorescein staining
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 23 Oct 2007.
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.
Jerry R Paugh, OD, PhD principal investigator
Southern California College of Optometry at Marshall B. Ketchum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-purpose solutions (polyquaternium-1 and PHMB) in people with Contact Lens Care, run by Southern California College of Optometry at Marshall B. Ketchum University 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 1 inclusion and 1 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 23 Oct 2007. 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?
Ratio of fluorescein dye penetration rate of test eye vs. control. 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 23 Oct 2007.