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
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