Contact Lens Solution ToxicityNCT00829751
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
A study testing PureVision lenses soaked in ReNu Multiplus and PureVision lenses soaked in OptiFree RePlenish in people with Contact Lens Solution Toxicity, 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 more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye. 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 Solution Toxicity
- What is being tested?
- PureVision lenses soaked in ReNu Multiplus and PureVision lenses soaked in OptiFree RePlenish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2011
- 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
- At least 18 years of age.
- Best correctable vision to 20/40 in each eye.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
- No known ocular or systemic allergies, which may interfere with contact lens wear.
- No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).
Who cannot join
- Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
- Are taking part in any other study or have taken part in a study within the last 14 days.
- Are pregnant, or anticipating to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry
Fullerton, California, 92831
About this study
The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.
- Conditions
- Contact Lens Solution Toxicity
- Being tested
- PureVision lenses soaked in ReNu Multiplus, PureVision lenses soaked in OptiFree RePlenish
- Keywords
- staining, toxicity, fluorometry, dye diffusion, anterior chamber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureVision lenses soaked in ReNu MultiplusDevice
Purevision silicone hydrogel lenses
PureVision lenses soaked in OptiFree RePlenishDevice
Purevision silicone hydrogel lenses soaked in OptiFree RePlenish
| Study group | Role | What they receive |
|---|---|---|
| ReNu Multiplus | Active comparator | Purevision lenses will be soaked in ReNu Multiplus Receives: Device: PureVision lenses soaked in ReNu Multiplus |
| OptiFree RePlenish | Active comparator | PureVision lenses will be soaked in OptiFree RePlenish Receives: Device: PureVision lenses soaked in OptiFree RePlenish |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints
Measured: On day of experiment
Secondary outcomes (1)
Corneal staining level post lens wear
Measured: On day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens Solution ToxicityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Jerry R. Paugh, OD, PhD, Southern California College of Optometry at Marshall B. Ketchum University
- 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
- NCT00829751
- Sponsor's protocol ID
- 08-8
- Status last verified
- May 2013
- First submitted
- 23 Jan 2009
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
- ClinicalTrials.gov ID
- NCT00829751
- Acronym / sponsor ID
- 08-8
- Conditions
- Contact Lens Solution Toxicity
- Keywords
- staining, toxicity, fluorometry, dye diffusion, anterior chamber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jan 2009 (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 more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReNu Multiplus | Active comparator | Device: PureVision lenses soaked in ReNu MultiplusPurevision lenses will be soaked in ReNu Multiplus |
| OptiFree RePlenish | Active comparator | Device: PureVision lenses soaked in OptiFree RePlenishPureVision lenses will be soaked in OptiFree RePlenish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age.
- Best correctable vision to 20/40 in each eye.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
- No known ocular or systemic allergies, which may interfere with contact lens wear.
- No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).
Key exclusion criteria (5 listed)
- Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
- Are taking part in any other study or have taken part in a study within the last 14 days.
- Are pregnant, or anticipating to become pregnant during the course of the study.
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 |
|---|---|---|
| PureVision lenses soaked in ReNu MultiplusPurevision silicone hydrogel lenses | Device | ReNu Multiplus |
| PureVision lenses soaked in OptiFree RePlenishPurevision silicone hydrogel lenses soaked in OptiFree RePlenish | Device | OptiFree RePlenish |
Primary outcome
The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints
Time frame: On day of experiment
1 secondary outcome
Corneal staining level post lens wear
Time frame: On day of study
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 4 Jun 2013.
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 PureVision lenses soaked in ReNu Multiplus and PureVision lenses soaked in OptiFree RePlenish in people with Contact Lens Solution Toxicity, 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 5 inclusion and 5 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 4 Jun 2013. 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?
The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints (time frame: On day of experiment). 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 4 Jun 2013.