Clinical trial NCT05079321: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Corneal Thickness
timeFrame: At screening
measure: Mean Corneal Thickness
timeFrame: After 4 weeks wear of coated lens
measure: Mean Corneal Thickness
timeFrame: After 4 weeks wear of uncoated lens
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: After 2 weeks of wear of coated lens
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: After 2 weeks of wear of uncoated lens
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: After 4 weeks of wear of coated lens
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: After 4 weeks of wear of uncoated lens
measure: Tear Film Osmolarity
timeFrame: At screening
measure: Tear Film Osmolarity
timeFrame: After 4 weeks of wear of uncoated lens
measure: Tear Film Osmolarity
timeFrame: After 4 weeks of wear of coated lens
measure: Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
timeFrame: After 4 weeks of wear of uncoated lens
measure: Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
timeFrame: After 4 weeks of wear of coated lens
measure: Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
timeFrame: At screening
measure: Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
timeFrame: After 4 weeks of wear of coated lens
measure: Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
timeFrame: After 4 weeks of wear of uncoated lens
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: School of Optometry & Vision Science, University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: