Ocular Effects of Scleral Lens Wear on Dry Eye Patients

NCT05079321 | Completed Results FDA Device

• 1 other identifier: 40887
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Coated Scleral Lens

EXPERIMENTAL

Participants wear a lens coated with Hydra-PEG.

Device: Hydra-PEG

Uncoated Scleral Lens

PLACEBO COMPARATOR

Participants wear an uncoated (control) lens.

Device: Uncoated

Interventions

Hydra-PEG DEVICE

Zen™ RC scleral lenses (Hydra-PEG coated)

Coated Scleral Lens

Uncoated DEVICE

Zen™ RC scleral lenses (non-coated)

Uncoated Scleral Lens

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Lyndon Jones
• Organization: Centre for Ocular Research and Education

lwjones@uwaterloo.ca

(519) 888-4567

Study Officials

• Lyndon Jones, PhD, FCOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 15, 2021
• Study Start: April 14, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2023-11

Locations

CA (1)