Contact Lens Disinfecting SolutionsPhase 4NCT00560898
Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function
A Phase 4 study testing ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution, Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution and Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution in people with Contact Lens Disinfecting Solutions, 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 measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Disinfecting Solutions
- What is being tested?
- ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution, Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution and Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2008
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
- Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
- Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
- Best correctable visual acuity of at least 20/40 in each eye.
- Willing to de-adapt (do not wear) from habitual contact lenses for periods of three days prior to barrier function determination.
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- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
- 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 lens wear (i.e. antihistamines, beta-blockers, steroids).
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.
- Less than one month successful, full time (defined as more than 8 hours per day, and more than 5 days per week) soft lens wear.
- Systemic disease or uses of medication, which may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than grade 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.
- Any active ocular infection.
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- Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
- Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
- Are taking part in any other study or have taken part in a study within the last 14 days
- Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
- Are pregnant, or anticipate becoming pregnant during the course of this study.
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 Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function
The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration. These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact lens wearers will participate.
- Conditions
- Contact Lens Disinfecting Solutions
- Being tested
- ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution, Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution, Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution, ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
- Keywords
- staining, epithelial barrier function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProClear Lens Material soaked in ReNu Multiplus Multipurpose SolutionDrug
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose SolutionDrug
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose SolutionDrug
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
ProClear Lens Material soaked in Optifree RepleniSH Multipurpose SolutionDrug
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | contact lenses disinfected in multipurpose solution Receives: Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution |
| 3 | Experimental | contact lenses disinfected in multipurpose solution Receives: Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution |
| 4 | Experimental | contact lenses disinfected in multipurpose solution Receives: Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution |
| 1 | Experimental | contact lenses disinfected in multipurpose solution Receives: Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial penetration rate of sodium fluoeescein, in nm/sec
Measured: Immediately post measurement
Secondary outcomes (1)
Corneal staining
Measured: Immediately following barrier determination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens Disinfecting SolutionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT00560898
- Sponsor's protocol ID
- 00001418
- Other IDs
- 00001418
- Status last verified
- May 2008
- First submitted
- 15 Nov 2007
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function
- ClinicalTrials.gov ID
- NCT00560898
- Acronym / sponsor ID
- 00001418
- Conditions
- Contact Lens Disinfecting Solutions
- Keywords
- staining, epithelial barrier function
- Phase
- Phase 4
- 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
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Nov 2007 (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 measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration. These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact lens wearers will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solutioncontact lenses disinfected in multipurpose solution |
| 3 | Experimental | Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solutioncontact lenses disinfected in multipurpose solution |
| 4 | Experimental | Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solutioncontact lenses disinfected in multipurpose solution |
| 1 | Experimental | Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solutioncontact lenses disinfected in multipurpose solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age.
Key exclusion criteria (11 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.
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 |
|---|---|---|
| ProClear Lens Material soaked in ReNu Multiplus Multipurpose SolutionContact lens soaked in multipuprpose solution for 8 hours, then worn for two hours | Drug | 2 |
| Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose SolutionContact lens soaked in multipuprpose solution for 8 hours, then worn for two hours | Drug | 3 |
| Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose SolutionContact lens soaked in multipuprpose solution for 8 hours, then worn for two hours | Drug | 4 |
| ProClear Lens Material soaked in Optifree RepleniSH Multipurpose SolutionContact lens soaked in multipuprpose solution for 8 hours, then worn for two hours | Drug | 1 |
Primary outcome
Epithelial penetration rate of sodium fluoeescein, in nm/sec
Time frame: Immediately post measurement
1 secondary outcome
Corneal staining
Time frame: Immediately following barrier determination
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 20 May 2008.
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 Phase 4 study testing ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution, Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution and Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution in people with Contact Lens Disinfecting Solutions, 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 9 inclusion and 11 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 20 May 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Epithelial penetration rate of sodium fluoeescein, in nm/sec (time frame: Immediately post measurement). 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 20 May 2008.