Dry Eye
Conditions
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.
Interventions
DEVICEHydra-PEG
Zen™ RC scleral lenses (Hydra-PEG coated)
DEVICEUncoated
Zen™ RC scleral lenses (non-coated)
Sponsors
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Corneal Thickness | At screening | Mean corneal thickness as measured with Pentacam HR (µm) |
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 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). |
| Tear Film Osmolarity | At screening | Tear film osmolarity measures with a Tearlab Osmolarity System |
| Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score | 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. |
| Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | At screening | Percentage of participants with a positive MMP-9 test, as measured by InflammaDry |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
Of 30 enrolled participants, 28 met inclusion criteria and 25 were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Overall Group All suitable participants eligible to take part in the study. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Overall Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 28.79 years STANDARD_DEVIATION 7.61 |
| Race/Ethnicity, Customized Race African/Black | 2 Participants |
| Race/Ethnicity, Customized Race Arab | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 12 Participants |
| Race/Ethnicity, Customized Race Caucasian | 8 Participants |
| Race/Ethnicity, Customized Race Indian | 4 Participants |
| Region of Enrollment Canada | 28 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
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).
Time frame: After 2 weeks of wear of uncoated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 19.40 score on a scale | Standard Deviation 7.34 |
| Uncoated/Coated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 17.20 score on a scale | Standard Deviation 6.55 |
p-value: 0.49t-test, 2 sided
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).
Time frame: After 4 weeks of wear of uncoated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 18.60 score on a scale | Standard Deviation 7.99 |
| Uncoated/Coated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 15.10 score on a scale | Standard Deviation 7.65 |
p-value: 0.33t-test, 2 sided
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).
Time frame: After 4 weeks of wear of coated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 13.50 score on a scale | Standard Deviation 7.07 |
| Uncoated/Coated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 19.50 score on a scale | Standard Deviation 6.64 |
p-value: 0.07t-test, 2 sided
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).
Time frame: After 2 weeks of wear of coated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 14.10 score on a scale | Standard Deviation 7.92 |
| Uncoated/Coated Scleral Lens | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 20.30 score on a scale | Standard Deviation 5.56 |
p-value: 0.06t-test, 2 sided
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.
Time frame: After 4 weeks of wear of coated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score | 40.70 score on a scale | Standard Deviation 9.49 |
| Uncoated/Coated Scleral Lens | Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score | 40.54 score on a scale | Standard Deviation 11.31 |
p-value: 0.97t-test, 2 sided
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.
Time frame: After 4 weeks of wear of uncoated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score | 37.66 score on a scale | Standard Deviation 13.37 |
| Uncoated/Coated Scleral Lens | Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score | 39.67 score on a scale | Standard Deviation 9.78 |
p-value: 0.71t-test, 2 sided
Primary
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Time frame: After 4 weeks wear of coated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Mean Corneal Thickness | 552.70 microns | Standard Deviation 26.96 |
| Uncoated/Coated Scleral Lens | Mean Corneal Thickness | 559.85 microns | Standard Deviation 35.31 |
p-value: 0.36t-test, 2 sided
Primary
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Time frame: At screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Mean Corneal Thickness | 570.54 microns | Standard Deviation 38.97 |
| Uncoated/Coated Scleral Lens | Mean Corneal Thickness | 560.73 microns | Standard Deviation 31.48 |
p-value: 0.25t-test, 2 sided
Primary
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Time frame: After 4 weeks wear of uncoated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Mean Corneal Thickness | 556.91 microns | Standard Deviation 29.83 |
| Uncoated/Coated Scleral Lens | Mean Corneal Thickness | 556.87 microns | Standard Deviation 29.92 |
p-value: 1t-test, 2 sided
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
Time frame: After 4 weeks of wear of uncoated lens
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coated/Uncoated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 50 percentage of participants |
| Uncoated/Coated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 60 percentage of participants |
p-value: 0.69Fisher Exact
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
Time frame: At screening
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coated/Uncoated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 83.33 percentage of participants |
| Uncoated/Coated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 84.62 percentage of participants |
p-value: 0.75Fisher Exact
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
Time frame: After 4 weeks of wear of coated lens
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coated/Uncoated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 80 percentage of participants |
| Uncoated/Coated Scleral Lens | Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film | 70 percentage of participants |
p-value: 0.59Fisher Exact
Primary
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Time frame: At screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Tear Film Osmolarity | 313.29 mOsm/l | Standard Deviation 22.18 |
| Uncoated/Coated Scleral Lens | Tear Film Osmolarity | 309.69 mOsm/l | Standard Deviation 16.32 |
p-value: 0.65t-test, 2 sided
Primary
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Time frame: After 4 weeks of wear of coated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Tear Film Osmolarity | 304.40 mOsm/l | Standard Deviation 8.48 |
| Uncoated/Coated Scleral Lens | Tear Film Osmolarity | 303.90 mOsm/l | Standard Deviation 11.57 |
p-value: 0.91t-test, 2 sided
Primary
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Time frame: After 4 weeks of wear of uncoated lens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coated/Uncoated Scleral Lens | Tear Film Osmolarity | 300.00 mOsm/l | Standard Deviation 12.87 |
| Uncoated/Coated Scleral Lens | Tear Film Osmolarity | 306.05 mOsm/l | Standard Deviation 12.87 |