Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Study Overview
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Brief Summary
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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.

Official Title
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Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Hydra-PEG
* Device: Uncoated


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coated Scleral Lens<br>Participants wear a lens coated with Hydra-PEG. | Device: Hydra-PEG<br>* Zen™ RC scleral lenses (Hydra-PEG coated)<br>|
| Placebo Comparator: Uncoated Scleral Lens<br>Participants wear an uncoated (control) lens. | Device: Uncoated<br>* Zen™ RC scleral lenses (non-coated)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm) | At screening | 
| Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm) | Immediately after dispense of coated lens | 
| Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm) | Immediately after dispense of uncoated lens | 
| Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm) | After 4 weeks wear of coated lens | 
| Mean Corneal Thickness | Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm) | After 4 weeks wear of uncoated lens | 
| 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). | After 2 weeks of wear of coated lens | 
| 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). | After 2 weeks of wear of uncoated lens | 
| 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). | After 4 weeks of wear of coated lens | 
| 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). | 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 | The 28-item CLIQ questionnaire contains five responses (none = score 1; little = score 2; moderate = score 3; extreme = score 4 and unable = score 5). | After 1 week of wear of uncoated lens | 
| 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). | After 1 week of wear of coated lens | 
| 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). | After 2 weeks of wear of uncoated lens | 
| 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). | After 2 weeks of wear of coated lens | 
| 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). | After 3 weeks of wear of uncoated lens | 
| 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). | After 3 weeks of wear of coated lens | 
| 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). | After 4 weeks of wear of uncoated lens | 
| 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). | After 4 weeks of wear of coated lens | 
| Inflammatory marker level in tear film | Level of MMP-9, as measured by InflammaDry | At screening | 
| Inflammatory marker level in tear film | Level of MMP-9, as measured by InflammaDry | After 4 weeks of wear of coated lens | 
| Inflammatory marker level in tear film | Level of MMP-9, as measured by InflammaDry | After 4 weeks of wear of uncoated lens |