Revive Toric RWE Study

Launched by BAUSCH & LOMB INCORPORATED · Jan 16, 2025

Keywords

ClinConnect Summary

The Revive Toric RWE Study is a clinical trial that aims to understand how well a specific type of contact lens, called the REVIVE samfilcon B custom toric lenses, works for people with astigmatism. This study will observe how these lenses perform in real-life settings and how satisfied healthcare professionals are with them. The trial is not yet recruiting participants, but it is open to adults aged 18 and older who have experience wearing soft contact lenses and meet certain health criteria.

To participate, individuals must have healthy eyes without any active diseases or allergies, and they should not be using any eye medications. Participants will need to be able to follow instructions and provide written consent to join the study. Those who have had previous eye surgeries or are taking medications that might affect their eyes are not eligible. If you qualify, you can expect to wear these lenses and share your experiences, helping to contribute valuable information about their effectiveness for people with astigmatism.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be 18 years or older on the date the ICF is signed
• • 2. Have the capacity to read, understand, and provide written voluntary informed consent
• • 3. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
• • 4. Have no active ocular disease or allergic conjunctivitis
• • 5. Not be using any topical ocular medications
• • 6. Be willing and able to follow instructions
• • 7. Have signed a statement of informed consent
• • 8. Be an experienced soft contact lens wearer (have previously used soft contact lenses)
• • 9. Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device
• Exclusion Criteria:
• • 1. Is participating in another research study
• • 2. Is considered by the Investigator to not be a suitable candidate for participation
• • 3. Is not eligible for treatment with the study lens per the IFU (contraindicated)
• • 4. Has had previous ocular surgery
• • 5. Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance