Trials Sponsors Conditions Drugs Pricing

Conditions

Contact Lens Wear

Keywords

Soft Contact LensSoft Contact Lenses

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

EXPERIMENTAL

Participants 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).

Device: Custom Samfilcon B Contact LensesDevice: ReNu MultiPlus Lubricating and Rewetting DropsDevice: Biotrue Multi-Purpose Solution

Alden Optical HP Sphere contact lenses

PLACEBO COMPARATOR

Participants 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.

Device: Alden Optical HP Sphere Contact Lens

Interventions

Custom Samfilcon B Contact LensesDevice

Contact lens

Custom Samfilcon B Contact Lenses

Alden Optical HP Sphere Contact LensDevice

Hioxifilcon D, 54% water, Alden Optical HP Sphere lens

Also known as: Alden Optical® HP Sphere lens

Alden Optical HP Sphere contact lenses

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

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.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

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

Johnson Varughese
Bausch & Lomb Incorporated
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

84 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Custom Samfilcon B Contact Lenses

Alden Optical HP Sphere contact lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Custom Samfilcon B Contact Lenses

Alden Optical HP Sphere contact lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations