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

NCT02701556 | Completed Results

• 1 other identifier: 872
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Wear

Outcome Measures

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).

  3 months

Study Arms (2)

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

EXPERIMENTAL

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

Device: NNR06

COMPLETE MPS

ACTIVE COMPARATOR

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

Device: Complete MPS

Interventions

Complete MPS DEVICE

a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.

COMPLETE MPS

NNR06 DEVICE

an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.

Also known as: Experimental Solution

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Is a habitual wearer of one of the following lens types:
• Lens Group Lens Material Trade Name Manufacturer
• Etafilcon A Acuvue2 Vistakon
• A Balafilcon A PureVision2 Bausch + Lomb
• C Samfilcon A Ultra Bausch + Lomb
• Cm Lotrafilcon B Optix Aqua Alcon
• Cr Senofilcon A Oasys Vistakon
• \. Is correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
• \. 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.
• \. 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.
• \. Is willing and able to comply with all treatment and follow-up/study procedures.

You may not qualify if:

• \. Has worn gas permeable (GP) lenses within the last 30 days.
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• \. 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.
• \. Is amblyopic. 14. Has had any corneal surgery (e.g., refractive surgery). 15. Is allergic to any component in the study care products.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Kannarr EyeCare

Pittsburg, Kansas, 66762, United States

Location

Results Point of Contact

• Title: Johnson Varughese
• Organization: Valeant Pharmaceuticals

johnson.varughese@bauschhealth.com

908 927-1162

Study Officials

• Johnson Varughese

  Valeant Pharmaceutcals NA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: March 8, 2016
• Study Start: May 31, 2015
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: February 8, 2022
• Results First Posted: May 31, 2017

Record last verified: 2022-02

Locations

US (1)