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

Primary Purpose

Refractive Ametropia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REVIVE Contact Lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Ametropia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy 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.

Sites / Locations

  • Bausch & Lomb, IncorporatedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REVIVE™ Toric Soft Contact Lenses

Arm Description

Outcomes

Primary Outcome Measures

Mean logMAR Visual Acuity at 6m
Mean logMAR Visual Acuity at 6m

Secondary Outcome Measures

Full Information

First Posted
September 19, 2023
Last Updated
October 4, 2023
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT06053736
Brief Title
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Official Title
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Ametropia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REVIVE™ Toric Soft Contact Lenses
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
REVIVE Contact Lens
Intervention Description
REVIVE Contact Lens
Primary Outcome Measure Information:
Title
Mean logMAR Visual Acuity at 6m
Description
Mean logMAR Visual Acuity at 6m
Time Frame
At one week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery Schafer
Phone
5857544680
Email
jeffery.schafer@bausch.com
Facility Information:
Facility Name
Bausch & Lomb, Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bausch &L Incorporated

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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