Refractive AmetropiaNCT06053736
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
A study testing REVIVE Toric Soft Contact Lenses in people with Refractive Ametropia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Ametropia, Astigmatism
- What is being tested?
- REVIVE Toric Soft Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 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
Who cannot join
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. If subjects satisfied all eligibility criteria and none of the exclusion criteria, subjects were fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses were trialed. Once vision and lens fit were determined to be acceptable, eligible subjects wore study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses were worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements were taken at the insertion visit and at the 7-day follow-up visit.
- Conditions
- Refractive Ametropia, Astigmatism
- Being tested
- REVIVE Toric Soft Contact Lenses
- Keywords
- REVIVE™, toric, soft contact lens, astigmatism, dispensing
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVIVE Toric Soft Contact LensesDevice
Also called REVIVE™ (hioxifilcon D)
Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week.
| Study group | Role | What they receive |
|---|---|---|
| REVIVE™ Toric Soft Contact Lenses | Experimental | Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week. Receives: Device: REVIVE Toric Soft Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean logMAR Visual Acuity at 6m
Mean binocular high-contrast, high-illumination (HCHI) logMAR visual acuity at 6 meters, measured with the REVIVE™ Toric study contact lenses in place at the 1-week follow-up visit. Acuity was recorded on a logMAR chart (each letter = 0.02 logMAR); lower/more-negative values indicate better visual acuity.
Measured: 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start4 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive AmetropiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects wore the same test lens (REVIVE™ Toric) for approximately 1 week.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Schafer, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053736
- Sponsor's protocol ID
- ROC2-23-008
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06053736
- Acronym / sponsor ID
- ROC2-23-008
- Conditions
- Refractive Ametropia, Astigmatism
- Keywords
- REVIVE™, toric, soft contact lens, astigmatism, dispensing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. If subjects satisfied all eligibility criteria and none of the exclusion criteria, subjects were fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses were trialed. Once vision and lens fit were determined to be acceptable, eligible subjects wore study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses were worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements were taken at the insertion visit and at the 7-day follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects wore the same test lens (REVIVE™ Toric) for approximately 1 week.
| Arm | Type | Receives |
|---|---|---|
| REVIVE™ Toric Soft Contact Lenses | Experimental | Device: REVIVE Toric Soft Contact LensesSubjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 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.
Key exclusion criteria (2 listed)
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
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 Toric Soft Contact LensesAlso: REVIVE™ (hioxifilcon D)Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week. | Device | REVIVE™ Toric Soft Contact Lenses |
Primary outcome
Mean logMAR Visual Acuity at 6m
Time frame: 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)
Mean binocular high-contrast, high-illumination (HCHI) logMAR visual acuity at 6 meters, measured with the REVIVE™ Toric study contact lenses in place at the 1-week follow-up visit. Acuity was recorded on a logMAR chart (each letter = 0.02 logMAR); lower/more-negative values indicate better visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffery Schafer study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVIVE Toric Soft Contact Lenses in people with Refractive Ametropia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean logMAR Visual Acuity at 6m (time frame: 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing 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 25 Aug 2026.