Ocular Effects of Scleral Lens Wear on Dry Eye Patients

April 17, 2025 updated by: University of Waterloo
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Corneal Thickness
Time Frame: At screening
Mean corneal thickness as measured with Pentacam HR (µm)
At screening
Mean Corneal Thickness
Time Frame: After 4 weeks wear of coated lens
Mean corneal thickness as measured with Pentacam HR (µm)
After 4 weeks wear of coated lens
Mean Corneal Thickness
Time Frame: After 4 weeks wear of uncoated lens
Mean corneal thickness as measured with Pentacam HR (µm)
After 4 weeks wear of uncoated lens
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).
After 2 weeks of wear of coated lens
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).
After 2 weeks of wear of uncoated lens
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).
After 4 weeks of wear of coated lens
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).
After 4 weeks of wear of uncoated lens
Tear Film Osmolarity
Time Frame: At screening
Tear film osmolarity measures with a Tearlab Osmolarity System
At screening
Tear Film Osmolarity
Time Frame: After 4 weeks of wear of uncoated lens
Tear film osmolarity measures with a Tearlab Osmolarity System
After 4 weeks of wear of uncoated lens
Tear Film Osmolarity
Time Frame: After 4 weeks of wear of coated lens
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
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.
After 4 weeks of wear of uncoated lens
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.
After 4 weeks of wear of coated lens
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
At screening
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
After 4 weeks of wear of coated lens
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
After 4 weeks of wear of uncoated lens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Waterloo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lyndon Jones, PhD, FCOptom, University of Waterloo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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