Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02588573
• Collaborator: (none)
• Enrollment: 103
• Locations: 2
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 51.5
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A (control); Device: somofilcon A (test)	N/A

Detailed Description

This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Etafilcon A (control) Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.	Device: etafilcon A (control); contact lens; Device: somofilcon A (test); contact lens
Active Comparator: Somofilcon A (test) Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.	Device: etafilcon A (control); contact lens; Device: somofilcon A (test); contact lens

Outcome Measures

Primary Outcome Measures

1. Comfort [8 hours]

   Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.

2. Comfort Preference [Baseline and 8 hours]

   Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens

3. Bulbar Hyperemia [Baseline and 8 hours]

   Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

4. Limbal Hyperemia [Baseline and 8 hours]

   Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

5. Conjunctival Staining [8 hours]

   Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central

6. Visual Acuity [Baseline and 8 hours]

   High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

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

5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);

6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;

7. Demonstrates an acceptable fit with the study lenses;

8. Is usually able to wear contact lenses for at least 8 hours per day.

Exclusion Criteria:

• A person will be excluded from the study if he/she:

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 substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;

6. Is aphakic;

7. Has undergone refractive error surgery.

8. Has participated in the previous somfofilcon A study (ORE# 20893)

• For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Contact Lens Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02588573
• Other Study ID Numbers: EX-MKTG-61
• First Posted: Oct 28, 2015
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Of the 103 enrolled, 13 participants were not eligible due to screen failure. This reporting group includes 90 participants (180 eyes) belonging to 2 groups of 45 habitual wearers of either etafilcon A lens or frequent replacement lenses (FREQ). All participants were randomized to wear etafilcon A in one eye and somofilcon A in the fellow eye.

Arm/Group Title	Habitual Etafilcon A Wearers	Habitual FREQ Wearers
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study	Habitual wearers of other frequent replacement lenses (FREQ) were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study.
Period Title: Overall Study
STARTED	45	45
Randomized Eye Etafilcon A	45	45
Randomized Eye Somofilcon A	45	45
COMPLETED	45	45
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A	Habitual FREQ Wearers Wearing Etafilcon A/Somofilcon A	Total
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study.	Total of all reporting groups
Overall Participants	45	45	90
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	25	25	25
Sex: Female, Male (Count of Participants)
Female	35 77.8%	37 82.2%	72 80%
Male	10 22.2%	8 17.8%	18 20%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers Randomized to Etafilcon A	Habitual Etafilcon A Wearers Randomized to Somofilcon A	Habitual FREQ Wearers Randomized to Etafilcon A	Habitual FREQ Wearers Randomized to Somofilcon A
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. etafilcon A (control): contact lens	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. somofilcon A (test): contact lens	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. etafilcon A (control): contact lens	Habitual wearers frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. somofilcon A (test): contact lens
Measure Participants	45	45	45	45
Measure eyes	45	45	45	45
Mean (Standard Deviation) [units on a scale]	83 (17)	77 (22)	83 (14)	83 (16)

2. Primary Outcome

Title	Comfort Preference
Description	Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens
Time Frame	Baseline and 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers - Baseline	Habitual FREQ Wearers - Baseline	Habitual Etafilcon A Wearers - 8hrs	Habitual FREQ Wearers - 8hrs
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
Measure Participants	45	45	45	45
Strongly Prefer Etafilcon A Lens	7 15.6%	3 6.7%	13 14.4%	2 NaN
Slightly Prefer Etafilcon A Lens	14 31.1%	10 22.2%	11 12.2%	16 NaN
No Preference	12 26.7%	19 42.2%	5 5.6%	10 NaN
Slightly Prefer Somofilcon A Lens	10 22.2%	11 24.4%	9 10%	8 NaN
Strongly Prefer Somofilcon A Lens	2 4.4%	2 4.4%	7 7.8%	9 NaN

3. Primary Outcome

Title	Bulbar Hyperemia
Description	Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time Frame	Baseline and 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers Randomized to Etafilcon A	Habitual Etafilcon A Wearers Randomized to Somofilcon A	Habitual FREQ Wearers Randomized to Etafilcon A	Habitual FREQ Wearers Randomized to Somofilcon A
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
Measure Participants	45	45	45	45
Measure eyes	45	45	45	45
Baseline	1.3 (0.4)	1.3 (0.4)	1.2 (0.4)	1.2 (0.4)
8 hours	1.3 (0.4)	1.3 (0.4)	1.2 (0.4)	1.2 (0.4)

4. Primary Outcome

Title	Limbal Hyperemia
Description	Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time Frame	Baseline and 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers Randomized to Etafilcon A	Habitual Etafilcon A Wearers Randomized to Somofilcon A	Habitual FREQ Wearers Randomized to Etafilcon A	Habitual FREQ Wearers Randomized to Somofilcon A
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
Measure Participants	45	45	45	45
Measure eyes	45	45	45	45
Baseline	1.2 (0.5)	1.2 (0.5)	1.0 (0.4)	1.0 (0.4)
8 hours	1.2 (0.4)	1.3 (0.4)	1.4 (0.5)	1.3 (0.4)

5. Primary Outcome

Title	Conjunctival Staining
Description	Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers Randomized to Etafilcon A	Habitual Etafilcon A Wearers Randomized to Somofilcon A	Habitual FREQ Wearers Randomized to Etafilcon A	Habitual FREQ Wearers Randomized to Somofilcon A
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
Measure Participants	45	45	45	45
Measure eyes	45	45	45	45
Nasal	1.0 (0.8)	1.1 (1.0)	1.1 (1.0)	1.4 (1.0)
Temporal	0.4 (0.5)	1.1 (0.9)	0.6 (0.6)	1.4 (1.0)
Superior	0.3 (0.5)	0.6 (0.8)	0.2 (0.5)	0.9 (0.8)
Inferior	0.6 (0.7)	1.1 (1.0)	0.6 (0.8)	1.2 (1.2)

6. Primary Outcome

Title	Visual Acuity
Description	High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Time Frame	Baseline and 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Etafilcon A Wearers Randomized to Etafilcon A	Habitual Etafilcon A Wearers Randomized to Somofilcon A	Habitual FREQ Wearers Randomized to Etafilcon A	Habitual FREQ Wearers Randomized to Somofilcon A
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.	Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
Measure Participants	45	45	45	45
Measure eyes	45	45	45	45
Baseline	-0.05 (0.07)	-0.05 (0.09)	-0.07 (0.06)	-0.06 (0.08)
8 hours	-0.06 (0.08)	-0.06 (0.10)	-0.07 (0.08)	-0.06 (0.08)

Adverse Events

Time Frame	8 hours
Adverse Event Reporting Description	Adverse events will be monitored for during the follow-up visit.
Arm/Group Title	Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp		Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp		Etafilcon A Lens (Control) Worn by Habitual FREQ Grp		Somofilcon A Lens (Test) Worn by Habitual FREQ Grp
Arm/Group Description	Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.		Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.		Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.		Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
All Cause Mortality
	Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp		Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp		Etafilcon A Lens (Control) Worn by Habitual FREQ Grp		Somofilcon A Lens (Test) Worn by Habitual FREQ Grp
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp		Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp		Etafilcon A Lens (Control) Worn by Habitual FREQ Grp		Somofilcon A Lens (Test) Worn by Habitual FREQ Grp
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)		0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp		Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp		Etafilcon A Lens (Control) Worn by Habitual FREQ Grp		Somofilcon A Lens (Test) Worn by Habitual FREQ Grp
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)		0/45 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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