Revive Toric RWE Study

Not yet recruiting

• Conditions: Astigmatism

• Registration Number: NCT06785194
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator overall satisfaction as assessed by the Investigator Survey	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)

Trial Locations

Locations (3)

Site 101; 🇺🇸 Orange Park, Florida, United States

Site 102; 🇺🇸 Orange Park, Florida, United States

Site 103; 🇺🇸 Canton, Georgia, United States