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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coated Scleral Lens | Experimental | Participants wear a lens coated with Hydra-PEG. |
|
| Uncoated Scleral Lens | Placebo Comparator | Participants wear an uncoated (control) lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydra-PEG | Device | Zen™ RC scleral lenses (Hydra-PEG coated) |
| |
| 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). |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry & Vision Science, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
Of 30 enrolled participants, 28 met inclusion criteria and 25 were randomized to treatment.
Participants were recruited at a single site between April 2022 and October 2022. The first participant was enrolled on April 14, 2022 and the last participant was enrolled on October 25, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coated/Uncoated Scleral Lens | Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated) |
| FG001 | Uncoated/Coated Scleral Lens | Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All suitable participants eligible to participate in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Group | All suitable participants eligible to take part in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR (µm) | Posted | Mean | Standard Deviation | microns | At screening |
|
Maximum of three months
Regular investigator assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coated Scleral Lens | Participants wore lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndon Jones | Centre for Ocular Research and Education | (519) 888-4567 | 35030 | lwjones@uwaterloo.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2021 | Aug 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Uncoated |
| Device |
Zen™ RC scleral lenses (non-coated) |
|
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
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| Primary | Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR (µm) | Posted | Mean | Standard Deviation | microns | After 4 weeks wear of coated lens |
|
|
|
|
| Primary | Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR (µm) | Posted | Mean | Standard Deviation | microns | After 4 weeks wear of uncoated lens |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | After 2 weeks of wear of coated lens |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | After 2 weeks of wear of uncoated lens |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of wear of coated lens |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of wear of uncoated lens |
|
|
|
|
| Primary | Tear Film Osmolarity | Tear film osmolarity measures with a Tearlab Osmolarity System | Posted | Mean | Standard Deviation | mOsm/l | At screening |
|
|
|
|
| Primary | Tear Film Osmolarity | Tear film osmolarity measures with a Tearlab Osmolarity System | Posted | Mean | Standard Deviation | mOsm/l | After 4 weeks of wear of uncoated lens |
|
|
|
| Primary | Tear Film Osmolarity | Tear film osmolarity measures with a Tearlab Osmolarity System | Posted | Mean | Standard Deviation | mOsm/l | After 4 weeks of wear of coated lens |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of wear of uncoated lens |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of wear of coated lens |
|
|
|
|
| Primary | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | Percentage of participants with a positive MMP-9 test, as measured by InflammaDry | Posted | Number | percentage of participants | At screening |
|
|
|
|
| Primary | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | Percentage of participants with a positive MMP-9 test, as measured by InflammaDry | Posted | Number | percentage of participants | After 4 weeks of wear of coated lens |
|
|
|
|
| Primary | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | Percentage of participants with a positive MMP-9 test, as measured by InflammaDry | Posted | Number | percentage of participants | After 4 weeks of wear of uncoated lens |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Uncoated Scleral Lens | Participants wore uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated) | 0 | 23 | 0 | 23 | 0 | 23 |
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