Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function
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ClinicalTrials.gov Identifier: NCT00560898 |
Recruitment Status
:
Completed
First Posted
: November 20, 2007
Last Update Posted
: May 20, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contact Lens Disinfecting Solutions | Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 2
contact lenses disinfected in multipurpose solution
|
Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Experimental: 3
contact lenses disinfected in multipurpose solution
|
Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Experimental: 4
contact lenses disinfected in multipurpose solution
|
Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Experimental: 1
contact lenses disinfected in multipurpose solution
|
Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
- Epithelial penetration rate of sodium fluoeescein, in nm/sec [ Time Frame: Immediately post measurement ]
- Corneal staining [ Time Frame: Immediately following barrier determination ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
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.
- 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).
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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560898
United States, California | |
Southern California College of Optometry | |
Fullerton, California, United States, 92831 |
Principal Investigator: | Jerry R Paugh, OD, PhD | Southern California College of Optometry |
ClinicalTrials.gov Identifier: | NCT00560898 History of Changes |
Other Study ID Numbers: |
00001418 |
First Posted: | November 20, 2007 Key Record Dates |
Last Update Posted: | May 20, 2008 |
Last Verified: | May 2008 |
Keywords provided by Southern California College of Optometry:
staining epithelial barrier function |
Additional relevant MeSH terms:
Pharmaceutical Solutions |