Revive Toric RWE Study | NCT06785194

Studies
Revive Toric RWE Study

NCT06785194

Sponsor

Bausch & Lomb Incorporated

Status

Not yet recruiting

Last Update Posted

Nov 28, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Astigmatism

Interventions

REVIVE samfilcon B custom toric contact lenses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Jan 16, 2025

First Submission Date that Met QC Criteria

Jan 16, 2025

First Posted Date

Jan 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Nov 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
REVIVE samfilcon B custom toric contact lenses		REVIVE samfilcon B custom toric contact lenses	Device: REVIVE samfilcon B custom toric contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
REVIVE samfilcon B custom toric contact lenses	Device	REVIVE samfilcon B custom toric contact lenses	REVIVE samfilcon B custom toric contact lenses

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient population at study site locations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marjorie Rah	Contact	585-413-6397		Marjorie.Rah@bausch.com
Victoria Panagakis	Contact	+44 (0) 7967 756 504		victoria.panagakis@panacea85.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 101		Orange Park	Florida	32073	United States
Site 102

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases