A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
1 other identifier
interventional
84
1 country
7
Brief Summary
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2019
CompletedFirst Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedResults Posted
Study results publicly available
October 26, 2022
CompletedNovember 14, 2022
September 1, 2022
6 months
March 29, 2019
May 4, 2022
November 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Distance High-contrast logMAR Lens VA
Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.
Month 3
Secondary Outcomes (1)
Proportion Of Eyes With Grade >2 Slit Lamp Findings
Month 3
Study Arms (2)
Custom Samfilcon B Contact Lenses
EXPERIMENTALParticipants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS).
Alden Optical HP Sphere contact lenses
PLACEBO COMPARATORParticipants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS.
Interventions
Hioxifilcon D, 54% water, Alden Optical HP Sphere lens
For use as needed during the study.
For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Eligibility Criteria
You may qualify if:
- Participants must be able to read, understand, and provide written informed consent on the institutional review board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- Participants must have clear central corneas and be free of any anterior segment disorders in each eye.
- Participants must be myopic, require contact lens correction from -1.00 diopter (D) to -6.00 D, and wear contact lenses in each eye.
- Participants must be correctable through spherocylindrical refraction to 47 letters (0.0 logMAR) or better (distance, high-contrast) in each eye.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
- Participants must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
You may not qualify if:
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal), who are currently pregnant, plan to become pregnant during the study, or are breastfeeding.
- Participants who have worn gas permeable lenses in either eye within the last 30 days or who have worn polymethylmethacrylate lenses in either eye within the last 3 months.
- Participants with any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease in either eye or who are using any ocular medication.
- Participants who currently wear monovision, multifocal, or toric contact lenses in either eye.
- Participants with an ocular astigmatism \>1.00 D in either eye.
- Participants with anisometropia (spherical equivalent) \>2.00 D.
- Participants with any Grade ≥2 finding in either eye during the slit lamp examination. Participants with corneal infiltrates in either eye, of any grade, are not eligible to participate in this study.
- Participants with any "present" finding during the slit lamp examination in either eye that, in the Investigator's judgment, interferes with contact lens wear.
- Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea in either eye. Note: participants 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 to participate in this study.
- Participants who are aphakic in either eye.
- Participants who are amblyopic in either eye.
- Participants who have had any corneal surgery (for example, refractive surgery) in either eye.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Bausch Site 1
San Francisco, California, 94112, United States
Bausch Site 2
Denver, Colorado, 80246, United States
Bausch Site 3
Sarasota, Florida, 34232, United States
Bausch Site 4
Pittsburg, Kansas, 66762, United States
Bausch Site 5
Warrensburg, Missouri, 64093, United States
Bausch Site 6
Vestal, New York, 13850, United States
Bausch Site 7
New Berlin, Wisconsin, 53151, United States
Results Point of Contact
- Title
- Johnson Varughese
- Organization
- Bausch & Lomb
Study Officials
- STUDY DIRECTOR
Johnson Varughese
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 1, 2019
Study Start
February 27, 2019
Primary Completion
August 28, 2019
Study Completion
August 28, 2019
Last Updated
November 14, 2022
Results First Posted
October 26, 2022
Record last verified: 2022-09