Clinical trial NCT03897712: A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
Official title: A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Soft Contact Lens
Soft Contact Lenses
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Participants who are allergic to any component in the study care products.
* Participants who meet any of the following criteria:

  1. The participant is an employee of the investigative site.
  2. The participant, or a member of the participant's household, is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician.
  3. The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, or Johnson \& Johnson).
  4. The participant, or a member of the participant's household, is an employee of a market research firm.

Primary outcomes:
measure: Mean Distance High-contrast logMAR Lens VA
timeFrame: Month 3
Secondary outcomes:
measure: Proportion Of Eyes With Grade >2 Slit Lamp Findings
timeFrame: Month 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bausch Site 1
state: California
city: Denver
country: United States
facility: Bausch Site 2
state: Colorado
city: Sarasota
country: United States
facility: Bausch Site 3
state: Florida
city: Pittsburg
country: United States
facility: Bausch Site 4
state: Kansas
city: Warrensburg
country: United States
facility: Bausch Site 5
state: Missouri
city: Vestal
country: United States
facility: Bausch Site 6
state: New York
city: New Berlin
country: United States
facility: Bausch Site 7
state: Wisconsin
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Johnson Varughese
role: STUDY_DIRECTOR
References: