Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Not Applicable

Completed

Conditions: Dry Eye

Interventions: Device: Hydra-PEG
Device: Uncoated

Registration Number: NCT05079321

Lead Sponsor: University of Waterloo

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coated Scleral Lens	Hydra-PEG	Participants wear a lens coated with Hydra-PEG.
Uncoated Scleral Lens	Uncoated	Participants wear an uncoated (control) lens.

Primary Outcome Measures

Name	Time	Method
Mean Corneal Thickness	After 4 weeks wear of uncoated lens	Mean corneal thickness as measured with Pentacam HR (µm)
Tear Film Osmolarity	After 4 weeks of wear of coated lens	Tear film osmolarity measures with a Tearlab Osmolarity System
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	After 4 weeks of wear of uncoated lens	The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	After 4 weeks of wear of coated lens	This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	After 4 weeks of wear of uncoated lens	Percentage of participants with a positive MMP-9 test, as measured by InflammaDry