Revive Toric RWE Study
Samfilcon B Custom Toric Lens Real-World Observational Study
1 other identifier
observational
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2026
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
November 28, 2025
November 1, 2025
2 months
January 16, 2025
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
REVIVE samfilcon B custom toric contact lenses
REVIVE samfilcon B custom toric contact lenses
Interventions
REVIVE samfilcon B custom toric contact lenses
Eligibility Criteria
Patient population at study site locations
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Site 101
Orange Park, Florida, 32073, United States
Site 102
Orange Park, Florida, 32073, United States
Site 103
Canton, Georgia, 30114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2025
First Posted
January 21, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
November 28, 2025
Record last verified: 2025-11