Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Dry Eye Clinical Trial

Official title:

Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079321
• Other study ID #: 40887
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: August 28, 2023

Study information

• Verified date: November 2023
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Hydra-PEG
Zen™ RC scleral lenses (Hydra-PEG coated)
• Uncoated
Zen™ RC scleral lenses (non-coated)

Locations

Country	Name	City	State
Canada	School of Optometry & Vision Science, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)	At screening
Primary	Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)	Immediately after dispense of coated lens
Primary	Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)	Immediately after dispense of uncoated lens
Primary	Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)	After 4 weeks wear of coated lens
Primary	Mean Corneal Thickness	Mean corneal thickness as measured with Pentacam HR and Spectralis OCT (µm)	After 4 weeks wear of uncoated lens
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Tear film osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	At screening
Primary	Tear film osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	After 4 weeks of wear of uncoated lens
Primary	Tear film osmolarity	Tear film osmolarity measures with a Tearlab Osmolarity System	After 4 weeks of wear of coated lens
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Inflammatory marker level in tear film	Level of MMP-9, as measured by InflammaDry	At screening
Primary	Inflammatory marker level in tear film	Level of MMP-9, as measured by InflammaDry	After 4 weeks of wear of coated lens
Primary	Inflammatory marker level in tear film	Level of MMP-9, as measured by InflammaDry	After 4 weeks of wear of uncoated lens