Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

NCT ID: NCT04037969

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2019-11-26

Brief Summary

The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.

Conditions

Evaporative Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Nesofilcon A/Delefilcon A

Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.

Group Type: EXPERIMENTAL

Nesofilcon A

Intervention Type: DEVICE

Hydrogel contact lens for daily wear

Delefilcon A

Intervention Type: DEVICE

Silicone hydrogel contact lens for daily wear

Delefilcon A/Nesofilcon A

Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.

Group Type: EXPERIMENTAL

Nesofilcon A

Intervention Type: DEVICE

Hydrogel contact lens for daily wear

Delefilcon A

Intervention Type: DEVICE

Silicone hydrogel contact lens for daily wear

Interventions

Nesofilcon A

Hydrogel contact lens for daily wear

Intervention Type: DEVICE

Delefilcon A

Silicone hydrogel contact lens for daily wear

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Has worn soft contact lenses for a minimum of 6 months;

5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;

6. Has an acceptable fit and comfort with both study contact lenses in the powers available;

7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;

8. Is willing to be awake for at least 2 hours before visit 2;

9. Is willing to not wear eye makeup on the day of visit 2 and 3;

10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;

11. Has a wearable pair of spectacles.

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to sodium fluorescein dye;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Has a known sensitivity to petroleum jelly (Vaseline);

10. Has epilepsy and/or a sensitivity to flashing lights;

11. Wears toric contact lenses;

12. Has any physical impairment that would interfere with holding the evaporimeter;

13. Has taken part in another research study within the last 14 days.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

41195

Identifier Type: -

Identifier Source: org_study_id