N/A N=25 Randomized Double-blind Treatment

Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT05079321 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Mean Corneal Thickness — 570.54; 560.73 microns — p=0.25

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hydra-PEG (Device); Uncoated (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Waterloo
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Corneal Thickness	556.91; 556.87	1.0
PRIMARY Mean Corneal Thickness	556.91; 556.87	1.0
PRIMARY Mean Corneal Thickness	556.91; 556.87	1.0
PRIMARY Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	18.60; 15.10	0.33
PRIMARY Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	18.60; 15.10	0.33
PRIMARY Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	18.60; 15.10	0.33
PRIMARY Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	18.60; 15.10	0.33
PRIMARY Tear Film Osmolarity	304.40; 303.90	0.91
PRIMARY Tear Film Osmolarity	304.40; 303.90	0.91
PRIMARY Tear Film Osmolarity	304.40; 303.90	0.91
PRIMARY Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	40.70; 40.54	0.97
PRIMARY Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	40.70; 40.54	0.97
PRIMARY Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	50; 60	0.69
PRIMARY Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	50; 60	0.69
PRIMARY Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	50; 60	0.69

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05079321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.