Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

Myopia Clinical Trial

Official title:

Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195893
• Other study ID #: EX-MKTG-112
• Status: Completed
• Phase: N/A
• Start date: November 24, 2019
• Est. completion date: March 11, 2020

Study information

• Verified date: August 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

Description:

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 11, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Subjects will only be eligible for the study if:

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. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;

5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;

6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;

7. Demonstrates an acceptable fit with the study lenses;

8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

• Subjects will not be eligible to take part in the study if:

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 the diagnostic pharmaceuticals to be used in the study;

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

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Is an employee of the Centre for Ocular Research & Education;

10. Has participated in the BEAGLE (EX-MKTG-104) study.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• somofilcon A
Contact Lens
• etafilcon A
Contact Lens

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Baseline
Other	Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	1 Day
Other	Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Day 3
Other	Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Day 5
Other	Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	1-Week
Primary	Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 1
Primary	Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 3
Primary	Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 5
Primary	Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	1 Week
Primary	Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 1
Primary	Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 3
Primary	Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 5
Primary	Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	1 week
Secondary	Lens Centration	Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus)	Baseline (after 10 minutes of lens fitting)
Secondary	Lens Centration	Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus)	1 week
Secondary	Post-blink Movement	Post-blink movement in primary gaze, in 0.1mm steps	Baseline (after 10 minutes of lens fitting)
Secondary	Post-blink Movement	Post-blink movement in primary gaze, in 0.1mm steps	1 -week
Secondary	Push-up Tightness	Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)	Baseline (after 10 minutes of lens fitting)
Secondary	Push-up Tightness	Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)	1 week