Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

NCT05973409 | Completed

• 1 other identifier: SEC-P052021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Habitual Soft Lens Wearers

EXPERIMENTAL

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

Non Contact Lens Wearers

EXPERIMENTAL

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

Interventions

scleral lens DEVICE

scleral lens with and without hydra-peg treatment

Habitual Soft Lens Wearers; Non Contact Lens Wearers

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead

Study Sites (1)

School of Optometry & Vision Sciences

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Lyndon Jones, PhD

  Director, Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: August 2, 2023
• Study Start: September 26, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CA (1)