Revive Toric RWE Study

Samfilcon B Custom Toric Lens Real-World Observational 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Astigmatism
• Intervention / Treatment: Device: REVIVE samfilcon B custom toric contact lenses

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Marjorie Rah; Phone Number: 585-413-6397; Email: Marjorie.Rah@bausch.com
• Study Contact Backup: Name: Victoria Panagakis; Phone Number: +44 (0) 7967 756 504; Email: victoria.panagakis@panacea85.com

Study Locations

• United States
  • Florida
    • Orange Park, Florida, United States, 32073
      • Site 101
    • Orange Park, Florida, United States, 32073
      • Site 102
  • Georgia
    • Canton, Georgia, United States, 30114
      • Site 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient population at study site locations

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
REVIVE samfilcon B custom toric contact lenses	Device: REVIVE samfilcon B custom toric contact lenses; REVIVE samfilcon B custom toric contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator overall satisfaction as assessed by the Investigator Survey	(completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit)	Assessed 14 days ± 3 days after the final dispensing/refinement visit

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: RWE-REV-P85-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No