Skip to main content
OpenTrials
Completed

NCT Number: NCT05079321

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydra-PEG

Device

Zen™ RC scleral lenses (Hydra-PEG coated)

Uncoated

Device

Zen™ RC scleral lenses (non-coated)

Primary outcomes

  1. Mean Corneal Thickness

    Time frame: At screening

    Mean corneal thickness as measured with Pentacam HR (µm)

  2. Mean Corneal Thickness

    Time frame: After 4 weeks wear of coated lens

    Mean corneal thickness as measured with Pentacam HR (µm)

  3. Mean Corneal Thickness

    Time frame: After 4 weeks wear of uncoated lens

    Mean corneal thickness as measured with Pentacam HR (µm)

  4. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    Time frame: After 2 weeks of wear of coated 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).

  5. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    Time frame: After 2 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).

  6. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    Time frame: After 4 weeks of wear of coated 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).

  7. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    Time frame: 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).

  8. Tear Film Osmolarity

    Time frame: At screening

    Tear film osmolarity measures with a Tearlab Osmolarity System

  9. Tear Film Osmolarity

    Time frame: After 4 weeks of wear of uncoated lens

    Tear film osmolarity measures with a Tearlab Osmolarity System

  10. Tear Film Osmolarity

    Time frame: After 4 weeks of wear of coated lens

    Tear film osmolarity measures with a Tearlab Osmolarity System

  11. Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

    Time frame: After 4 weeks of wear of uncoated 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.

  12. Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

    Time frame: 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.

  13. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Time frame: At screening

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

  14. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Time frame: After 4 weeks of wear of coated lens

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

  15. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Time frame: After 4 weeks of wear of uncoated lens

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2021
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.