Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Device: scleral lens

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Vega, OD, MSc, PhD; Phone Number: 925-621-3761; Email: jvega2@coopervision.com

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • School of Optometry & Vision Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD, Director, Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SEC-P052021

Drug and device information, study documents

• 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