1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Status
Conditions
Treatments
Details and patient eligibility
About
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Jeffery Schafer
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal