Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

Dry Eye Clinical Trial

Official title:

Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973409
• Other study ID #: SEC-P052021
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: Jose Vega, OD, MSc, PhD
• Phone: 925-621-3761
• Email: jvega2[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine if scleral lenses coated with Hydra-PED improve comfort and dryness.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• scleral lens
scleral lens with and without hydra-peg coating

Locations

Country	Name	City	State
Canada	School of Optometry & Vision Sciences	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4 weeks