Product Performance of a New Silicone Hydrogel Contact Lens

Myopia Clinical Trial

Official title:

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901897
• Other study ID #: 893
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: October 9, 2019

Study information

• Verified date: June 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.

• myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.

• correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.

• free of any anterior segment disorders.

• adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.

• access to internet connection and personal email to send/receive emails.

• habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion Criteria:

• participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.

• have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

• have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.

• using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.

• refractive astigmatism of greater than 0.75 D in either eye.

• anisometropia (spherical equivalent) of greater than 2.00 D.

• amblyopic.

• have had any corneal surgery (e.g., refractive surgery).

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• kalifilcon A
kalifilcon A daily disposable contact lens
• delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
• senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Locations

Country	Name	City	State
United States	Bausch Site 401	'Aiea	Hawaii
United States	Bausch Site 406	Azusa	California
United States	Bausch Site 433	Birmingham	Alabama
United States	Bausch 410	Brentwood	Tennessee
United States	Bausch Site 412	Decatur	Georgia
United States	Bausch Site 416	Denver	Colorado
United States	Bausch Site 429	Edina	Minnesota
United States	Bausch Site 411	Fargo	North Dakota
United States	Bausch Site 428	Grants Pass	Oregon
United States	Bausch Site 437	Honolulu	Hawaii
United States	Bausch Site 415	Jacksonville	Florida
United States	Bausch Site 434	Jacksonville	Florida
United States	Bausch Site 424	Jamestown	New York
United States	Bausch Site 426	League City	Texas
United States	Bausch Site 414	Leavenworth	Kansas
United States	Bausch Site 430	Los Angeles	California
United States	Bausch Site 408	Memphis	Tennessee
United States	Bausch Site 423	Miamisburg	Ohio
United States	Bausch Site 404	Nashville	Tennessee
United States	Bausch Site 413	Portland	Maine
United States	Bausch Site 417	Raleigh	North Carolina
United States	Bausch Site 422	Raytown	Missouri
United States	Bausch Site 407	Saint Louis	Missouri
United States	Bausch Site 419	San Diego	California
United States	Bausch Site 435	San Francisco	California
United States	Bausch Site 405	Sarasota	Florida
United States	Bausch Site 431	Scottsdale	Arizona
United States	Bausch Site 420	State College	Pennsylvania
United States	Bausch Site 421	Sterling Heights	Michigan
United States	Bausch Site 432	Sunnyvale	California
United States	Bausch Site 409	Torrance	California
United States	Bausch Site 403	Vestal	New York
United States	Bausch Site 418	Warrensburg	Missouri
United States	Bausch Site 427	Warwick	Rhode Island
United States	Bausch Site 425	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in logMAR Contact Lens Visual Acuity	logMAR is the logarithm of the minim angle of resolution	Baseline, 2 Week Follow up
Primary	Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"		2 Week Follow up
Primary	Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"		2 Week Follow up