AstigmatismNCT06785194
Revive Toric RWE Study
An observational study of Astigmatism, run by Bausch & Lomb Incorporated at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- REVIVE samfilcon B custom toric contact lenses
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2026to Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient population at study site locations
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 103
Canton, Georgia, 30114
Site 101
Orange Park, Florida, 32073
Site 102
Orange Park, Florida, 32073
About this study
Official title: 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.
- Conditions
- Astigmatism
- Being tested
- REVIVE samfilcon B custom toric contact lenses
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVIVE samfilcon B custom toric contact lensesDevice
REVIVE samfilcon B custom toric contact lenses
| Study group | Role | What they receive |
|---|---|---|
| REVIVE samfilcon B custom toric contact lenses | REVIVE samfilcon B custom toric contact lenses Receives: Device: REVIVE samfilcon B custom toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Assessed 14 days ± 3 days after the final dispensing/refinement visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study startMar 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: Lens manufacturing has been postponed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785194
- Sponsor's protocol ID
- RWE-REV-P85-001
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes