Study Stopped
Management Decision
Clinical Comparison of Toric Contact Lenses Fit Characteristics
1 other identifier
interventional
N/A
1 country
7
Brief Summary
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2023
Shorter than P25 for not_applicable
7 active sites
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
First Submitted
Initial submission to the registry
March 23, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMay 19, 2023
May 1, 2023
1 month
March 23, 2023
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance VA with study lenses
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
30 mins (± 15 mins), each product
Study Arms (4)
DT1fA/T30fA/AOHGfA/P1fA
OTHERDT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
T30fA/AOHGfA/P1fA/DT1fA
OTHERT30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
AOHGfA/P1fA/DT1fA/T30fA
OTHERAOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
P1fA/DT1fA/T30fA/AOHGfA
OTHERP1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Interventions
Commercially available silicone hydrogel contact lens
Commercially available silicone hydrogel contact lens
Commercially available silicone hydrogel contact lens
Commercially available silicone hydrogel contact lens
Eligibility Criteria
You may qualify if:
- Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
- Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
- Willing to stop wearing habitual contact lenses during in-office visits.
You may not qualify if:
- Current spherical, monovision or multifocal lens wearer.
- Protocol-specified biomicroscopy findings at screening.
- Current or history of herpetic keratitis in either eye.
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (7)
Kurata Eyecare Center
Los Angeles, California, 90013, United States
Omega Vision Center P.A.
Longwood, Florida, 32779, United States
Kindred Optics at Maitland Vision
Maitland, Florida, 32751, United States
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762, United States
ProCare Vision Centers, Inc.
Granville, Ohio, 43023, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
Clarke EyeCare Center
Wichita Falls, Texas, 76308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trial Lead, Vision Care
Alcon Research, LLC
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
March 23, 2023
First Posted
April 10, 2023
Study Start
April 1, 2023
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share