The objective of this study is to determine if specialty contact lenses with and without a “HydraPEG” lens coating can improve symptoms of dry eye. These specialty scleral lenses rest on the white part of the eye (sclera). Due to their design and fitting, they can help relieve ocular discomfort and dryness in dry eye patients. For this study we are looking for symptomatic soft lens wearers and non-lens wearers to be fit with these lenses.

Both dry eye and non-dry eye participants are being recruited as part of this study. Participants in the non-dry eye group are being invited to join a control group of people without dry eye. Participants in the non-dry eye group will be selected based on their age and biological sex to match a corresponding participant in the dry eye group.

About the study

This study involves at least 6 in-office visits.  The visits are:

• Visit 1 – Screening visit to determine eligibility 2hr 30min
• Visit 2 – Dispense study lens type #1 and lens training 2hr 30min
• Visit 3 – 2-week follow up of study lens type #1 1hr
• Visit 4 – 1-month follow up of study lens type #1 and dispense study lens type #1 2hr
• Visit 5 – 2-week follow up of study lens type #2 1hr
• Visit 6 – 1-month follow up of study lens type #2 and study exit 1hr 30min

Total in-office visit time commitment – estimated 10.5 hours

There are some questionnaires to be completed between study visits, estimated time commitment of 1 hour spread across the study period.

The visits will include standard clinical procedures that you might encounter when you attend an eye exam.

Participant requirements

• Age: At least 18 years old and have full legal capacity to volunteer
• Experiences symptoms of dry eye (symptomatic)
• In good ocular and general health and a full eye exam conducted in the last 2 years
• Have a prescription of sphere between +20.00 and -20.00D AND astigmatism up to -3.00DC in each eye
• Anticipate being able to wear the study lenses for at least 8 hours per day, 5 days per week for the duration of the study

Reimbursement

In appreciation of your time, you will receive $230 for completing 6 in-office, plus an additional $20 per hours if a lens modification is needed. All study contact lenses and solutions will be provided at no cost. If applicable, parking tokens will be provided.

How to participate

If you have questions about this study or would like more information, please call us on 519-888-4742 or email us at corestudies@uwaterloo.ca and mention the study name SEAHORSE.

If you are interested in participating, please create a volunteer profile at the link below and we will contact you with more information.  If you are already a registered CORE volunteer, please contact us using the link below and mention the study name SEAHORSE.

All studies conducted at CORE have been reviewed and received ethics clearance through a University of Waterloo Research Ethics Board.

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
  Wash-out period
• 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.

Participant requirements

• 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

Reimbursement

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 hotchere@uwaterloo.ca.

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 hotchere@uwaterloo.ca. 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.