Clinical trial NCT05973409: Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
Official title: Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 study lenses and the coating, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers.

The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).

Eligibility criteria: Inclusion Criteria:

1. Are at least 17 years of age and have full legal capacity to volunteer;
2. Have read and signed an information consent letter;
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
5. Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
6. Have best corrected visual acuity of 20/40 or better in each eye with the study lenses;
7. Demonstrate an acceptable fit with the study lenses;
8. Have no active ocular disease or inflammation;
9. Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;
10. Group 2: Have not worn contact lenses for 6 months;
11. Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;
12. Group 2: Non contact lens wearers should score ≥13 on OSDI.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
2. Cannot achieve a successful lens fit or vision with the study lens;
3. Have been diagnosed with keratoconus or corneal distortion;
4. Have any known active\* ocular condition, disease and/or infection;
5. Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
7. 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#;
8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;
9. Are pregnant, lactating or planning a pregnancy\^ at the time of enrolment, by self report;
10. Have undergone refractive error surgery;
11. Are listed on the Delegation Log for this study.

Primary outcomes:
measure: overall ocular comfort
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: School of Optometry & Vision Sciences
state: Ontario
Study officials:
affiliation: Director, Centre for Ocular Research and Education
name: Lyndon Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: