A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/13/2018 |
Start Date: | May 2015 |
End Date: | October 2015 |
The objective of this study is to evaluate the safety and effectiveness of NNR06
Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE
Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual
contact lens wearers to bilaterally clean and disinfect their contact lenses for
approximately three months.
Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE
Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual
contact lens wearers to bilaterally clean and disinfect their contact lenses for
approximately three months.
Approximately 398 subjects (796 eyes) will be enrolled in this three-month controlled,
parallel group, masked, randomized study at approximately 22 investigative sites in the
United States (US). Approximately one-half of the subjects will be randomized to receive
Bausch & Lomb investigational NNR06 Multi-Purpose Solution to be used with a rub care regimen
(Test), and approximately one-half of the subjects will be randomized to receive COMPLETE
Multi-Purpose Solution with a rub care regimen (Control).
parallel group, masked, randomized study at approximately 22 investigative sites in the
United States (US). Approximately one-half of the subjects will be randomized to receive
Bausch & Lomb investigational NNR06 Multi-Purpose Solution to be used with a rub care regimen
(Test), and approximately one-half of the subjects will be randomized to receive COMPLETE
Multi-Purpose Solution with a rub care regimen (Control).
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.
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