Contact Lens Wear
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEComplete MPS
a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
DEVICENNR06
an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bausch & Lomb Investigational NNR06 Multi-Purpose Solution B & L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses. | 197 |
| COMPLETE Multi-Purpose Solution B&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses. | 198 |
| Total | 395 |
Baseline characteristics
| Characteristic | Bausch & Lomb Investigational NNR06 Multi-Purpose Solution | COMPLETE Multi-Purpose Solution | Total |
|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 10 | 33.7 years STANDARD_DEVIATION 8.9 | 33.5 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 197 Participants | 198 Participants | 395 Participants |
| Sex: Female, Male Female | 143 Participants | 142 Participants | 285 Participants |
| Sex: Female, Male Male | 54 Participants | 56 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 197 | 0 / 198 |
| serious Total, serious adverse events | 0 / 197 | 0 / 198 |
Outcome results
Primary
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.
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).
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bausch & Lomb Investigational NNR06 Multi-Purpose Solution | 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. | 2 Participants |
| COMPLETE Multi-Purpose Solution | 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. | 4 Participants |