Revive Toric RWE Study

Bausch + Lomb

Status: Begins enrollment in 2 months

Conditions: Astigmatism

Treatments: Device: REVIVE samfilcon B custom toric contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT06785194

RWE-REV-P85-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

REVIVE samfilcon B custom toric contact lenses

Description:

REVIVE samfilcon B custom toric contact lenses

Treatment:

Device: REVIVE samfilcon B custom toric contact lenses