1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

NCT06053736 | Completed Results FDA Device

• 1 other identifier: ROC2-23-008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. If subjects satisfied all eligibility criteria and none of the exclusion criteria, subjects were fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses were trialed. Once vision and lens fit were determined to be acceptable, eligible subjects wore study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses were worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements were taken at the insertion visit and at the 7-day follow-up visit.

Conditions

Refractive Ametropia; Astigmatism

Keywords

REVIVE™, toric, soft contact lens, astigmatism, dispensing

Outcome Measures

Primary Outcomes (1)

• Mean logMAR Visual Acuity at 6m

  Mean binocular high-contrast, high-illumination (HCHI) logMAR visual acuity at 6 meters, measured with the REVIVE™ Toric study contact lenses in place at the 1-week follow-up visit. Acuity was recorded on a logMAR chart (each letter = 0.02 logMAR); lower/more-negative values indicate better visual acuity.

  1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)

Study Arms (1)

REVIVE™ Toric Soft Contact Lenses

EXPERIMENTAL

Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week.

Device: REVIVE Toric Soft Contact Lenses

Interventions

REVIVE Toric Soft Contact Lenses DEVICE

Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week.

Also known as: REVIVE™ (hioxifilcon D)

REVIVE™ Toric Soft Contact Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Have no active ocular disease or allergic conjunctivitis.
• Not be using any topical ocular medications.
• Be willing and able to follow instructions.
• Have signed a statement of informed consent

You may not qualify if:

• Participating in a conflicting study in the opinion of the Investigator.
• Considered by the Investigator to not be a suitable candidate for participation.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch + Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Due to the study timeline, it was expected that more participants would be screened and enrolled than would be dispensed study lenes and/or complete the study. If participants were discontinued from the study, their data was not included in the analysis.

Results Point of Contact

• Title: Jeffery Schafer, OD, MS Director, Clinical Research
• Organization: Bausch + Lomb

jeffery.schafer@bausch.com

585-603-2402

Study Officials

• Jeffery Schafer

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects wore the same test lens (REVIVE™ Toric) for approximately 1 week.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: October 4, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 25, 2026
• Results First Posted: August 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)