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OpenTrials
Completed

NCT Number: NCT06053736

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

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.

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Key information

Conditions

Refractive Ametropia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch + Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: REVIVE™ (hioxifilcon D)

Primary outcomes

  1. Mean logMAR Visual Acuity at 6m

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

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2023
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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