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CompletedNCT02701556Updated Feb 8, 2022Results posted

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

An interventional study of Complete MPS and NNR06 in Contact Lens Wear, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
396
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Contact Lens Wear
03

In context

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 41 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

  1. Is correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
  1. 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.
  1. 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.
  1. Is willing and able to comply with all treatment and follow-up/study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Has worn gas permeable (GP) lenses within the last 30 days.

    1. 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.

      1. 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.
      1. 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).
      1. 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.
      1. 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.
      1. Is amblyopic. 14. Has had any corneal surgery (e.g., refractive surgery). 15. Is allergic to any component in the study care products.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
396 participants (actual)

Study arms

  • Experimental
    Bausch & Lomb (B&L) NNR06 Multi-Purpose Solution (MPS)

    B \& L investigational NNR06 used as a rub care regimen (Test)

    Device: NNR06

  • Active comparator
    COMPLETE MPS

    B\&L Multi-Purpose Solution as a rub care regimen (Control)

    Device: Complete MPS

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.

    Also known as: Experimental Solution

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted May 31, 2017

Participant flow

Participant flow — Overall Study
MilestoneBausch & Lomb Investigational NNR06 Multi-Purpose SolutionCOMPLETE Multi-Purpose Solution
Started198198
Completed175178
Not completed2320

Outcome measures

PrimaryThe 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
Reported as:
Count of participants · Participants
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.
ParticipantsBausch & Lomb Investigational NNR06 Multi-Purpose SolutionCOMPLETE 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.24

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bausch & Lomb Investigational NNR06 Multi-Purpose Solution—0/197 (0%)0/197 (0%)
COMPLETE Multi-Purpose Solution—0/198 (0%)0/198 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Bausch & Lomb Investigational NNR06 Multi-Purpose SolutionCOMPLETE Multi-Purpose SolutionTotal
Mean33.2 ± 1033.7 ± 8.933.5 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)Bausch & Lomb Investigational NNR06 Multi-Purpose SolutionCOMPLETE Multi-Purpose SolutionTotal
Female143142285
Male5456110
Region of Enrollment
Region of Enrollment(Participants)Bausch & Lomb Investigational NNR06 Multi-Purpose SolutionCOMPLETE Multi-Purpose SolutionTotal
United States197198395
08

Study locations

1 site
  • Kannarr EyeCare
    Pittsburg, Kansas 66762, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02701556
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Mar 8, 2016
Start date
May 31, 2015
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015
Results posted
May 31, 2017
Last update
Feb 8, 2022

Study contacts

Johnson Varughese
study director · Valeant Pharmaceutcals NA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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