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
- Are there results?
- None posted in the registry
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samfilcon B Custom Toric Lens Real-World Observational Study
- ClinicalTrials.gov ID
- NCT06785194
- Acronym / sponsor ID
- RWE-REV-P85-001
- Conditions
- Astigmatism
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lens manufacturing has been postponed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REVIVE samfilcon B custom toric contact lenses | – | Device: REVIVE samfilcon B custom toric contact lensesREVIVE samfilcon B custom toric contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient population at study site locations
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REVIVE samfilcon B custom toric contact lensesREVIVE samfilcon B custom toric contact lenses | Device | REVIVE samfilcon B custom toric contact lenses |
Primary outcome
Investigator overall satisfaction as assessed by the Investigator Survey
Time frame: Assessed 14 days ± 3 days after the final dispensing/refinement visit
(completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism, run by Bausch & Lomb Incorporated at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator overall satisfaction as assessed by the Investigator Survey (time frame: Assessed 14 days ± 3 days after the final dispensing/refinement visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.