Status:
UNKNOWN
Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
Lead Sponsor:
CooperVision, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
17-70 years
Phase:
NA
Brief Summary
This study is being conducted to determine if scleral lenses coated with Hydra-PED improve comfort and dryness.
Detailed Description
The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG coating provide positive improvement in ocular comfort and dryness scores. The effect of the stu...
Eligibility Criteria
Inclusion
- Are at least 17 years of age and have full legal capacity to volunteer;
- Have read and signed an information consent letter;
- Are willing and able to follow instructions and maintain the appointment schedule;
- Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
- Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
- Have best corrected visual acuity of 20/40 or better in each eye with the study lenses;
- Demonstrate an acceptable fit with the study lenses;
- Have no active ocular disease or inflammation;
- Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;
- Group 2: Have not worn contact lenses for 6 months;
- Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;
- Group 2: Non contact lens wearers should score ≥13 on OSDI.
Exclusion
- Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
- Cannot achieve a successful lens fit or vision with the study lens;
- Have been diagnosed with keratoconus or corneal distortion;
- Have any known active\* ocular condition, disease and/or infection;
- Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#;
- Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Are pregnant, lactating or planning a pregnancy\^ at the time of enrolment, by self report;
- Have undergone refractive error surgery;
- Are listed on the Delegation Log for this study.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05973409
Start Date
August 1 2023
End Date
August 1 2023
Last Update
August 2 2023
Active Locations (1)
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1
School of Optometry & Vision Sciences
Waterloo, Ontario, Canada, N2L 3G1