Back to resultsOcular Effects of Scleral Lens Wear on Dry Eye Patients
Primary Purpose
Dry Eye
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hydra-PEG
Uncoated
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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.
Sites / Locations
- School of Optometry & Vision Science, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Coated Scleral Lens
Uncoated Scleral Lens
Arm Description
Participants wear a lens coated with Hydra-PEG.
Participants wear an uncoated (control) lens.
Outcomes
Primary Outcome Measures
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
he 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 Dry Eye Questionnaire (CLDEQ-8) Score
he 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 Dry Eye Questionnaire (CLDEQ-8) Score
he 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 Dry Eye Questionnaire (CLDEQ-8) Score
he 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).
Tear film osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Tear film osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Tear film osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Inflammatory marker level in tear film
Level of MMP-9, as measured by InflammaDry
Inflammatory marker level in tear film
Level of MMP-9, as measured by InflammaDry
Inflammatory marker level in tear film
Level of MMP-9, as measured by InflammaDry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05079321
Brief Title
Ocular Effects of Scleral Lens Wear on Dry Eye Patients
Official Title
Ocular Effects of Scleral Lens Wear on Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
July 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coated Scleral Lens
Arm Type
Experimental
Arm Description
Participants wear a lens coated with Hydra-PEG.
Arm Title
Uncoated Scleral Lens
Arm Type
Placebo Comparator
Arm Description
Participants wear an uncoated (control) lens.
Intervention Type
Device
Intervention Name(s)
Hydra-PEG
Intervention Description
Zen™ RC scleral lenses (Hydra-PEG coated)
Intervention Type
Device
Intervention Name(s)
Uncoated
Intervention Description
Zen™ RC scleral lenses (non-coated)
Primary Outcome Measure Information:
Title
Mean Corneal Thickness
Description
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Time Frame
At screening
Title
Mean Corneal Thickness
Description
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Time Frame
Immediately after dispense of coated lens
Title
Mean Corneal Thickness
Description
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Time Frame
Immediately after dispense of uncoated lens
Title
Mean Corneal Thickness
Description
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Time Frame
After 4 weeks wear of coated lens
Title
Mean Corneal Thickness
Description
Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)
Time Frame
After 4 weeks wear of uncoated lens
Title
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Description
he 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).
Time Frame
After 2 weeks of wear of coated lens
Title
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Description
he 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).
Time Frame
After 2 weeks of wear of uncoated lens
Title
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Description
he 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).
Time Frame
After 4 weeks of wear of coated lens
Title
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Description
he 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).
Time Frame
After 4 weeks of wear of uncoated lens
Title
Tear film osmolarity
Description
Tear film osmolarity measures with a Tearlab Osmolarity System
Time Frame
At screening
Title
Tear film osmolarity
Description
Tear film osmolarity measures with a Tearlab Osmolarity System
Time Frame
After 4 weeks of wear of uncoated lens
Title
Tear film osmolarity
Description
Tear film osmolarity measures with a Tearlab Osmolarity System
Time Frame
After 4 weeks of wear of coated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 1 week of wear of uncoated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 1 week of wear of coated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 2 weeks of wear of uncoated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 2 weeks of wear of coated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 3 weeks of wear of uncoated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 3 weeks of wear of coated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 4 weeks of wear of uncoated lens
Title
Contact Lens Impact on Quality of Life (CLIQ) questionnaire score
Description
The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5).
Time Frame
After 4 weeks of wear of coated lens
Title
Inflammatory marker level in tear film
Description
Level of MMP-9, as measured by InflammaDry
Time Frame
At screening
Title
Inflammatory marker level in tear film
Description
Level of MMP-9, as measured by InflammaDry
Time Frame
After 4 weeks of wear of coated lens
Title
Inflammatory marker level in tear film
Description
Level of MMP-9, as measured by InflammaDry
Time Frame
After 4 weeks of wear of uncoated lens
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FCOptom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry & Vision Science, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Ocular Effects of Scleral Lens Wear on Dry Eye Patients
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