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Not yet recruiting NCT06785194

Revive Toric RWE Study

— Observational Astigmatism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REVIVE samfilcon B custom toric contact lenses.
Who it may be relevant to
Registry conditions: Astigmatism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Samfilcon B Custom Toric Lens Real-World Observational Study

Overview

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.

Interventions

  • Device REVIVE samfilcon B custom toric contact lenses
    REVIVE samfilcon B custom toric contact lenses

Primary outcome measures

  • Investigator overall satisfaction as assessed by the Investigator Survey [Time frame: Assessed 14 days ± 3 days after the final dispensing/refinement visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • Site 101 — Orange Park
  • Site 102 — Orange Park
  • Site 103 — Canton

Identifiers

NCT: NCT06785194 · RWE-REV-P85-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗