Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03226353
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 28.2

Study Details

Study Description

Brief Summary

The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

• Investigator responses to refit questions;

• Lens fit.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: somofilcon A; Device: omafilcon A	N/A

Detailed Description

This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
• Actual Study Start Date: Jul 6, 2017
• Actual Primary Completion Date: Sep 27, 2017
• Actual Study Completion Date: Sep 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A 1-day soft contact lenses Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week	Device: somofilcon A; contact lens; Device: omafilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? [1 week]

   Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)

2. Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? [1 week]

   Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)

3. Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? [1 week]

   Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)

4. Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? [1 week]

   Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)

5. Lens Fit - Post-blink Lens Movement [Dispense and 1 Week]

   Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.

6. Lens Fit - Lens Tightness [Dispense and 1 week]

   Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.

7. Lens Fit - Lens Deposition [Dispense and 1 week]

   Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.

8. Lens Fit - Centration [Dispense and 1 Week]

   (3 point scale: optimum, decentration acceptable, decentration unacceptable)

9. Lens Fit - Lens Wettability [Dispense and 1 Week]

   Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.

10. Overall Lens Fit Acceptance [Dispense and 1 Week]

    Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• Has read and signed an information consent letter;

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

• Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;

• Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;

• Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;

• Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;

• Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Exclusion Criteria:

• Is participating in any concurrent clinical research study;

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

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

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

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);

• Is aphakic;

• Has undergone refractive error surgery;

• Is an employee of the Centre for Contact Lens Research;

• Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 4, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03226353
• Other Study ID Numbers: EX-MKTG-84
• First Posted: Jul 21, 2017
• Last Update Posted: Sep 12, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of Omafilcon A were refitted with Somofilcon A
Period Title: Overall Study
STARTED	77
Habitual Wearers of Proclear 1 Day	2
Other Habitual Lens Types	75
COMPLETED	71
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of omafilcon A were refitted with somofilcon A. Two participants were habitual wearers of omafilcon A; the remaining participants were habitual wearers of other lens types. One participant was excluded from all analysis due to protocol deviation and one participant was excluded from all analysis due to an adverse event.
Overall Participants	71
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	71 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (7.6)
Sex: Female, Male (Count of Participants)
Female	52 73.2%
Male	19 26.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	71 100%

Outcome Measures

1. Primary Outcome

Title	Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
Description	Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day
Measure Participants	69
Strongly disagree	1 1.4%
Disagree	0 0%
Slightly disagree	13 18.3%
Slightly Agree	11 15.5%
Agree	32 45.1%
Styrongly agree	12 16.9%

2. Primary Outcome

Title	Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
Description	Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day
Measure Participants	69
Strongly disagree	0 0%
Disagree	2 2.8%
Slightly disagree	18 25.4%
Slightly agree	20 28.2%
Agree	18 25.4%
Strongly agree	11 15.5%

3. Primary Outcome

Title	Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
Description	Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day
Measure Participants	69
Strongly disagree	1 1.4%
Disagree	3 4.2%
Slightly disagree	30 42.3%
Sligtly agree	19 26.8%
Agree	14 19.7%
Strongly Agree	2 2.8%

4. Primary Outcome

Title	Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
Description	Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day
Measure Participants	69
Strongly Disagree	1 1.4%
Disagree	2 2.8%
Slightly Disagree	19 26.8%
Slightly agree	22 31%
Agree	19 26.8%
Strongly agree	6 8.5%

5. Primary Outcome

Title	Lens Fit - Post-blink Lens Movement
Description	Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Time Frame	Dispense and 1 Week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Dispense	2.1 (0.5)	2.2 (0.5)
1-week	1.9 (0.6)	2.0 (0.6)

6. Primary Outcome

Title	Lens Fit - Lens Tightness
Description	Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Time Frame	Dispense and 1 week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Dispense	48 (9)	46 (7)
1-week	51 (8)	47 (9)

7. Primary Outcome

Title	Lens Fit - Lens Deposition
Description	Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.
Time Frame	Dispense and 1 week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Dispense	0.38 (0.54)	0.22 (0.33)
1-week	0.60 (0.63)	0.36 (0.51)

8. Primary Outcome

Title	Lens Fit - Centration
Description	(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Time Frame	Dispense and 1 Week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Optimum	26 36.6%	40 NaN
Acceptable	43 60.6%	27 NaN
Unacceptable	0 0%	0 NaN
Optimum	28 39.4%	35 NaN
Acceptable	41 57.7%	34 NaN
Unacceptable	0 0%	0 NaN

9. Primary Outcome

Title	Lens Fit - Lens Wettability
Description	Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Time Frame	Dispense and 1 Week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Dispense	0.54 (0.66)	0.21 (0.34)
1-week	0.83 (0.78)	0.42 (0.25)

10. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less
Time Frame	Dispense and 1 Week

Outcome Measure Data

Analysis Population Description

71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis

Arm/Group Title	Somofilcon A	Omafilcon A
Arm/Group Description	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.	All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Measure Participants	69	69
Dispense	3.3 (0.6)	3.6 (0.5)
1-week	3.2 (0.7)	3.4 (0.7)

Adverse Events

Time Frame	From dispense to completion of follow up, approximately one week for each lens, two weeks total.
Arm/Group Title	Somofilcon A		Omafilcon A
Arm/Group Description	Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types.		Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types.
All Cause Mortality
	Somofilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Serious Adverse Events
	Somofilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.