Status:
COMPLETED
Total30 For Contact Lens Dropouts
Lead Sponsor:
Southern College of Optometry
Collaborating Sponsors:
Alcon Research
Conditions:
Dry Eye
Contact Lens Complication
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "e...
Detailed Description
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "e...
Eligibility Criteria
Inclusion
- Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
- Participants will be required to have worn reusable CLs for at least one year in the past.
- Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
- Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
- This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
- a. Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.
- . Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
- Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
- Participants will be required to provide a prescription for glasses that is less than 3 years old.
Exclusion
- if they are past rigid CL wearers,
- have worn reusable CLs within the past two years,
- have a history of being diagnosed with dry eye or ocular allergies,
- have known systemic health conditions that are thought to alter tear film physiology,
- have a history of viral eye disease,
- have a history of ocular surgery,
- have a history of severe ocular trauma,
- have a history of corneal dystrophies or degenerations,
- have active ocular infection or inflammation,
- are currently using isotretinoin-derivatives or ocular medications, or
- if they are pregnant or breast feeding.
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06967298
Start Date
April 23 2024
End Date
November 28 2024
Last Update
December 3 2025
Active Locations (1)
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1
The Southern College of Optometry
Memphis, Tennessee, United States, 38104