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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05565937
Collaborator
(none)
340
Enrollment
2
Arms
3.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.

Condition or Disease Intervention/Treatment Phase
  • Drug: BL-3100-NBR03 multi-purpose solution
  • Drug: renu® Advanced Formula multi-purpose solution
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BL-3100-NBR03

BL-3100-NBR03 multi-purpose solution

Drug: BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
Active Comparator: renu® Advanced Formula

renu® Advanced Formula multi-purpose solution

Drug: renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses

Outcome Measures

Primary Outcome Measures

  1. Overall comfort averaged over all scheduled follow-up visits [3 months]

    Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response

  2. Vision averaged over all scheduled follow-up visits [3 months]

    Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response

  3. The proportion of eyes with a maximum degree of front surface deposits grade of < 2 over all scheduled follow-up visits [3 months]

    The degree of front surface deposits will be graded for each eye as 0, 1, 2, 3, or 4.

  4. The proportion of eyes with any slit-lamp findings greater than Grade 2 over all follow-up visits. [3 months]

    Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed

  2. Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations

  3. Is a habitual wearer (at least 3 months)

  4. Has typically cleaned and disinfected their pre-study contact lenses daily

  5. Has typically replaced their pre-study contact lenses monthly

  6. Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart

  7. Has clear central corneas and is free of any anterior segment disorders

  8. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses

  9. Requires lens correction in both eyes

  10. Wears the same manufacturer and brand of lens in both eyes

  11. Agrees to wear study lenses on a daily wear basis for approximately three months

  12. Is willing and able to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

  1. Is currently using a hydrogen-peroxide cleaning and disinfecting solution

  2. Participated in any drug or device clinical investigation within 30 days prior to entry into this study

  3. Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:

  • they are currently pregnant

  • they plan to become pregnant during the study

  • they are breastfeeding

  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 typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year

  4. 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

  5. Has any ocular disease, or is using any ocular medication.

  6. Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance

  7. Currently wears monovision, multifocal, or toric contact lenses

  8. Has ocular astigmatism of 1.00D or greater in either eye

  9. Has anisometropia (spherical equivalent) of greater than 2.00D

  10. Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)

  11. Has corneal infiltrates, of ANY GRADE

  12. Has any "Present" ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear

  13. Has any scar or neovascularization within the central 6 mm of the cornea, irregular cornea or a history of herpetic keratitis

◊ Note that subjects with minor peripheral corneal scarring (that does not extend into the 6 mm central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.

  1. Is aphakic

  2. Is amblyopic

  3. Has had any corneal surgery (e.g., refractive surgery)

  4. Is allergic to any component in the study care products.

  5. Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household

  6. Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties

  7. Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Daniel Donatello, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT05565937
Other Study ID Numbers:
  • 914
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Refractive Errors
Pharmaceutical Solutions

Study Results

No Results Posted as of Oct 4, 2022