The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
This study has been completed.
Sponsor:
Southern California College of Optometry
Collaborator:
Alcon Laboratories
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00829751
First received: January 23, 2009
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Contact Lens Solution Toxicity |
Device: PureVision lenses soaked in ReNu Multiplus Device: PureVision lenses soaked in OptiFree RePlenish |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility |
Further study details as provided by Southern California College of Optometry:
Primary Outcome Measures:
- The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints [ Time Frame: On day of experiment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Corneal staining level post lens wear [ Time Frame: On day of study ] [ Designated as safety issue: Yes ]
| Enrollment: | 26 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ReNu Multiplus
Purevision lenses will be soaked in ReNu Multiplus
|
Device: PureVision lenses soaked in ReNu Multiplus
Purevision silicone hydrogel lenses
|
|
Active Comparator: OptiFree RePlenish
PureVision lenses will be soaked in OptiFree RePlenish
|
Device: PureVision lenses soaked in OptiFree RePlenish
Purevision silicone hydrogel lenses soaked in OptiFree RePlenish
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.).
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829751
Locations
| United States, California | |
| Southern California College of Optometry | |
| Fullerton, California, United States, 92831 | |
Sponsors and Collaborators
Southern California College of Optometry
Alcon Laboratories
Investigators
| Principal Investigator: | Jerry R Paugh, OD, PhD | Southern California College of Optometry |
More Information
No publications provided
| Responsible Party: | Jerry R. Paugh, OD, PhD, PI, Southern California College of Optometry |
| ClinicalTrials.gov Identifier: | NCT00829751 History of Changes |
| Other Study ID Numbers: | 08-8 |
| Study First Received: | January 23, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern California College of Optometry:
|
staining toxicity fluorometry dye diffusion anterior chamber |
ClinicalTrials.gov processed this record on May 16, 2013