An interventional study of ReNu Multiplus multipurpose disinfecting solution and Control in Contact Lens-induced Corneal Fluorescein Staining, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to assess corneal staining and to measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact lens and multipurpose lens care solution combination.
This investigation will evaluate corneal staining and epithelial barrier function after eight hours of contact lens wear, which is past the peak staining time and more typical of daily lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be used to evaluate potential corneal compromise. The study will be a prospective, single-center, double-masked, contralateral, daily wear investigation in adapted soft contact lens wearers. After a three day washout period (without lens wear, lenses will then be worn on one day for eight hours. Corneal staining and barrier function will be determined for a regimen and a saline control situation for each subject. Staining will be graded using the Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration rate, Pdc in nm/sec for the test and control condition.
Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Uses ReNu Multiplus as multipurpose soaking solution
Device: ReNu Multiplus multipurpose disinfecting solution
A new lens (PureVision) is soaked for 2 hours in non-preserved saline
Device: Control
A new lens (PureVision) soaked 6 hours to overnight in ReNu Multiplus
A new lens (PureVision) is soaked for two hours in non-preserved saline
The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes.
The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium.
Time frame: After eight hours of wear
Permeability Rate, nm/Sec
A penetration rate, in nm/sec
Time frame: After eight hours of wear
The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye.
Corneal staining represents corneal abrasion or damage. It is graded by us on a 0 - 4 scale (4 being worst) in five corneal sectors. The total score per cornea or eye is thus graded on a 0 - 20 total scale.
Time frame: After eight hours of wear
| Milestone | Test Eye | Control |
|---|---|---|
| Started | 30 | 30 |
| Completed | 26 | 26 |
| Not completed | 4 | 4 |
| Withdrew: Some subject data unuseable | 4 | 4 |
The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium.
| nanometers per second | PHMB-containing Disinfectant | Non-preserved Saline |
|---|---|---|
| The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. | 0.0567 ± 0.039 | 0.0583 ± 0.038 |
A penetration rate, in nm/sec
| nm/sec | Test Eye | Control |
|---|---|---|
| Permeability Rate, nm/Sec | 0.057 ± 0.04 | 0.058 ± 0.04 |
Corneal staining represents corneal abrasion or damage. It is graded by us on a 0 - 4 scale (4 being worst) in five corneal sectors. The total score per cornea or eye is thus graded on a 0 - 20 total scale.
| score on a scale | PHMB-containing Disinfectant | Non-preserved Saline |
|---|---|---|
| The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye. | 4.95 ± 2.4 | 4.52 ± 2.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Eye | — | 0/30 (0%) | 0/30 (0%) |
| Control | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 25.2 ± 2.1 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 19 |
| Male | 11 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 30 |
| Permeability Rate, Pdc(nanometers per second) | All Participants |
|---|---|
| Mean | 0.05749 ± 0.038 |
The record gives a start of Oct 2009, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2020, 10 years 8 months after primary completion.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Southern California College of Optometry at Marshall B. Ketchum University