Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05973409
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: scleral lens	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: At the fitting visit, only uncoated lenses will be used to determine the parameters of the lenses to be ordered. At both dispense visits, participants and investigators will be masked to the lens type dispensed. In order to achieve this, unmasked study personnel will determine the order of lens wear according to the randomization schedule and they will not share the lens labels or packs with the investigator. Instead, the lenses will be transferred to an unmarked case/container prior to being provided at the Dispense visit.
• Primary Purpose: Other
• Official Title: Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Habitual Soft Lens Wearers Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.	Device: scleral lens; scleral lens with and without hydra-peg coating
Experimental: Non Contact Lens Wearers Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.	Device: scleral lens; scleral lens with and without hydra-peg coating

Outcome Measures

Primary Outcome Measures

1. overall ocular comfort [4 weeks]

   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

Criteria

• Ages Eligible for Study: 17 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry & Vision Sciences	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD, Director, Centre for Ocular Research and Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT05973409
• Other Study ID Numbers: SEC-P052021
• First Posted: Aug 2, 2023
• Last Update Posted: Aug 2, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Aug 2, 2023