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1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06053736
Collaborator
(none)
40
Enrollment
1
Arm
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: REVIVE Contact Lens
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: REVIVE™ Toric Soft Contact Lenses

Device: REVIVE Contact Lens
REVIVE Contact Lens

Outcome Measures

Primary Outcome Measures

  1. Mean logMAR Visual Acuity at 6m [At one week follow up]

    Mean logMAR Visual Acuity at 6m

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. 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.

  2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

  3. Have no active ocular disease or allergic conjunctivitis.

  4. Not be using any topical ocular medications.

  5. Be willing and able to follow instructions.

  6. Have signed a statement of informed consent

Exclusion Criteria:

  1. Participating in a conflicting study in the opinion of the Investigator.

  2. Considered by the Investigator to not be a suitable candidate for participation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT06053736
Other Study ID Numbers:
  • ROC2-23-008
First Posted:
Sep 26, 2023
Last Update Posted:
Sep 26, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors

Study Results

No Results Posted as of Sep 26, 2023