Revive Toric RWE Study

NCT ID: NCT06785194

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-05-31

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Astigmatism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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REVIVE samfilcon B custom toric contact lenses

REVIVE samfilcon B custom toric contact lenses

REVIVE samfilcon B custom toric contact lenses

Intervention Type DEVICE

REVIVE samfilcon B custom toric contact lenses

Interventions

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REVIVE samfilcon B custom toric contact lenses

REVIVE samfilcon B custom toric contact lenses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 101

Orange Park, Florida, United States

Site Status

Site 102

Orange Park, Florida, United States

Site Status

Site 103

Canton, Georgia, United States

Site Status

Countries

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United States

Central Contacts

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Marjorie Rah

Role: CONTACT

585-413-6397

Victoria Panagakis

Role: CONTACT

+44 (0) 7967 756 504

Other Identifiers

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RWE-REV-P85-001

Identifier Type: -

Identifier Source: org_study_id

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