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NCT Number: NCT06785194

Revive Toric RWE Study

This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 101, Orange Park, Florida, United States

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Be 18 years or older on the date the ICF is signed
  • Have the 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
  • Be an experienced soft contact lens wearer (have previously used soft contact lenses)
  • Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device

Exclusion criteria

  • Is participating in another research study
  • Is considered by the Investigator to not be a suitable candidate for participation
  • Is not eligible for treatment with the study lens per the IFU (contraindicated)
  • Has had previous ocular surgery
  • Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance

Treatment and study plan

REVIVE samfilcon B custom toric contact lenses

Device

REVIVE samfilcon B custom toric contact lenses

Primary outcomes

  1. Investigator overall satisfaction as assessed by the Investigator Survey

    Time frame: Assessed 14 days ± 3 days after the final dispensing/refinement visit

    (completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit)

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Samfilcon B Custom Toric Lens Real-World Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Nov 28, 2025

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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