Ocular Effects of Scleral Lens Wear on Dry Eye Patients

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Hydra-PEG; Device: Uncoated

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coated Scleral Lens; Participants wear a lens coated with Hydra-PEG.	Device: Hydra-PEG; Zen™ RC scleral lenses (Hydra-PEG coated)
Placebo Comparator: Uncoated Scleral Lens; Participants wear an uncoated (control) lens.	Device: Uncoated; Zen™ RC scleral lenses (non-coated)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR (µm)	At screening
Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR (µm)	After 4 weeks wear of coated lens
Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR (µm)	After 4 weeks wear of uncoated lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	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).	After 2 weeks of wear of coated lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	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).	After 2 weeks of wear of uncoated lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	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).	After 4 weeks of wear of coated lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	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).	After 4 weeks of wear of uncoated lens
Tear Film Osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	At screening
Tear Film Osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	After 4 weeks of wear of uncoated lens
Tear Film Osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	After 4 weeks of wear of coated lens
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	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.	After 4 weeks of wear of uncoated lens
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	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.	After 4 weeks of wear of coated lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	Percentage of participants with a positive MMP-9 test, as measured by InflammaDry	At screening
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	Percentage of participants with a positive MMP-9 test, as measured by InflammaDry	After 4 weeks of wear of coated lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	Percentage of participants with a positive MMP-9 test, as measured by InflammaDry	After 4 weeks of wear of uncoated lens

Collaborators and Investigators

• Sponsor: University of Waterloo
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 40887

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes