Ocular Effects of Scleral Lens Wear on Dry Eye Patients

NCT ID: NCT05079321

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2023-08-28

Brief Summary

The purpose of this study is to investigate the effects of scleral contact lens wear on a DE population using coated (Hydra-PEG) and uncoated (control) lenses. Symptoms of DE, quality of the tear film, quality of life, epithelial and overall corneal thickness, vision and comfort will be assessed before and after dispensing and wearing the lenses for four weeks.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Coated Scleral Lens

Participants wear a lens coated with Hydra-PEG.

Group Type: EXPERIMENTAL

Hydra-PEG

Intervention Type: DEVICE

Zen™ RC scleral lenses (Hydra-PEG coated)

Uncoated Scleral Lens

Participants wear an uncoated (control) lens.

Group Type: PLACEBO_COMPARATOR

Uncoated

Intervention Type: DEVICE

Zen™ RC scleral lenses (non-coated)

Interventions

Hydra-PEG

Zen™ RC scleral lenses (Hydra-PEG coated)

Intervention Type: DEVICE

Uncoated

Zen™ RC scleral lenses (non-coated)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read, understood, and signed the information consent letter.
• Has been diagnosed with dry eyes.
• Has reduced tear break up time (NITBUT) and/or reduced tear meniscus height (TMH), clinical sign of dry eye disease and contact lens discomfort or is symptomatic of dry eye.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has greater than 13 points on the OSDI.
• Has greater than 4 points on the Standardized Patient Evaluation of Eye Dryness (SPEED).

Exclusion Criteria

A person will be excluded from the study if he/she:

• Is using any topical medications that will likely affect the study outcome.
• Has undergone any form of corneal surgery.
• Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye not related to the signs of dry eye.
• Has any clinically significant lid or conjunctival abnormalities and active neovascularization on the cornea.
• Anatomic variations of the conjunctiva that can impair proper scleral or soft contact lens wear/fitting
• Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration) which may significantly impact visual function and assessment.
• Is participating in any other type of eye related clinical or research study.
• Has any active ocular infection and may require topical medications.
• Currently taking any systemic medication that may affect the study outcome.
• Is pregnant
• Has been diagnosed, recovered, or tested positive but asymptomatic with COVID-19.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

40887

Identifier Type: -

Identifier Source: org_study_id