The objective of this study is to evaluate (compare) the ocular effects of two types of specialty (scleral) contact lenses and determine if they improve symptoms of dry eye. Two pairs of scleral lenses (one pair with a specialized coating on the surface, one pair without) will be worn during the study period.
We are looking for symptomatic lens wearers AND non-lens wearers who experience dry eye symptoms, aged 18 or older, to participate in this study. We will custom-fit these specialty scleral lenses, which rest on the white part of the eye (sclera). Due to their custom design and larger fit, these lenses are commonly used for dry eye management and can help relieve ocular discomfort in dry eye patients, including those who may have discontinued using soft contact lenses due to discomfort.
About the study
This study has 5 in-clinic visits spread across approximately a 2-month study duration:
- Visit 1 (0-0) – Screening and baseline measurement and custom lenses ordered – 2.5hrs
- Visit 2 (1-1) – Lens 1 delivery, training & assessments– 2 hrs
- Visit 3 (1-2) – Lens 1 follow-up visit after 4 weeks – 1.5 hrs
- Visit 4 (2-1) – Lens 2 delivery & assessments – 1.5hrs
- Visit 5 (2-2) – Lens2 follow-up visit after 4 weeks – 1.5hrs
Total in-visit time commitment – 9 hours
You will also be asked to complete 3 short questionnaires in between study visits (<1 hour total across the study).
The visits will include standard clinical procedures that you might encounter when you attend a routine eye exam. On each visit, both eyes will be assessed with and without contact lenses on the eye. Images will be taken with a series of instruments, and tear film samples will be collected using small strips designed for tear film analysis.
- Adults, aged 18 years or older
- Experiences symptoms of dry eye (symptomatic)
- In good ocular and general health and has had a full eye exam in the last 2 years
- Has a prescription of sphere between +20.00 and -20.00DS AND astigmatism up to-3.00DC in each eye
- Anticipates being able to wear the study lenses for at least 8 hours per day, 7 days per week, for the duration of the study
In appreciation of your time, you will receive $180 upon study completion. All study contact lenses and solutions will be provided. Parking passes will be provided as required.
How to participate
If you are interested in participating, please complete and return the attached pre-screening questionnaires by email to email@example.com.
For more information on the HEINZ study, visit http://COREstudies.ca/HEINZ .
If you have questions or would like more details, please contact me at firstname.lastname@example.org. You will be provided with all relevant study information prior to study enrollment, and you are under no obligation to participate.
This study has been reviewed and received ethics clearance through a University of Waterloo Research Ethics Board.