- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02701556
A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Pittsburg, Kansas, United States, 66762
- Kannarr EyeCare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Is a habitual wearer of one of the following lens types:
Lens Group Lens Material Trade Name Manufacturer
4 Etafilcon A Acuvue2 Vistakon
5-A Balafilcon A PureVision2 Bausch + Lomb
5-C Samfilcon A Ultra Bausch + Lomb
5-Cm Lotrafilcon B Optix Aqua Alcon
5-Cr Senofilcon A Oasys Vistakon
2. Is correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
3. Has clear central corneas and is free of any anterior segment disorders. 4. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses.
5. Requires lens correction in both eyes. 6. Wears the same manufacturer and brand of lens in both eyes. 7. Agrees to wear study lenses on a daily wear basis for approximately three months.
8. Is willing and able to comply with all treatment and follow-up/study procedures.
Exclusion Criteria:
1. Has worn gas permeable (GP) lenses within the last 30 days.
2. Has worn polymethylmethacrylate (PMMA) lenses within the last three months. 3. Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
4. Currently wears monovision, multifocal, or toric contact lenses. 5. Has ocular astigmatism of 1.00D or greater in either eye. 6. Is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
7. Has anisometropia (spherical equivalent) of greater than 2.00D 8. Has any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for Methods of Clinical Evaluation).
9. Has corneal infiltrates, of ANY GRADE. 10. Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
11. Has any scar or neovascularization within the central 4 mm of the cornea. Note that subjects with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. 12. Is aphakic.
13. Is amblyopic. 14. Has had any corneal surgery (e.g., refractive surgery). 15. Is allergic to any component in the study care products.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bausch & Lomb (B&L) NNR06 Multi-Purpose Solution (MPS)
B & L investigational NNR06 used as a rub care regimen (Test)
|
an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
Other Names:
|
ACTIVE_COMPARATOR: COMPLETE MPS
B&L Multi-Purpose Solution as a rub care regimen (Control)
|
a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.
Time Frame: 3 months
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A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes.
Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Johnson Varughese, Valeant Pharmaceutcals NA
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 872
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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