Orientation Characteristics of Daily Disposable Toric Contact Lenses
1 other identifier
interventional
30
1 country
1
Brief Summary
Brief summary: Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedFirst Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedResults Posted
Study results publicly available
July 1, 2025
CompletedJuly 1, 2025
June 1, 2025
4 days
September 19, 2023
September 24, 2024
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Gaze Orientation
Primary gaze orientation 5 minutes after lens insertion
Assessed 5 minutes after lens insertion
Study Arms (2)
kalifilcon A Daily Disposable Toric
EXPERIMENTALAcuvue Oasys 1-Day for Astigmatism
ACTIVE COMPARATORInterventions
kalifilcon A Daily Disposable Toric
Acuvue Oasys 1-Day for Astigmatism
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The subject is not eligible to participate in the study if the subject is:
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb, Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffery Schafer, OD, MS Director, Clinical Research
- Organization
- Bausch & Lomb
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2023
First Posted
October 6, 2023
Study Start
August 11, 2023
Primary Completion
August 15, 2023
Study Completion
August 15, 2023
Last Updated
July 1, 2025
Results First Posted
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share