Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03519932
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: comfilcon A toric lens; Device: samfilcon A toric lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism
• Actual Study Start Date: Apr 30, 2018
• Actual Primary Completion Date: Oct 15, 2018
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: comfilcon A toric lens Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.	Device: comfilcon A toric lens; Contact lens; Other Names: Biofinity toric test lens ; Device: samfilcon A toric lens; Contact lens; Other Names: Ultra for Astigmatism control lens
Active Comparator: samfilcon A toric lens Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.	Device: comfilcon A toric lens; Contact lens; Other Names: Biofinity toric test lens ; Device: samfilcon A toric lens; Contact lens; Other Names: Ultra for Astigmatism control lens

Outcome Measures

Primary Outcome Measures

1. Comfort at Insertion [Dispense]

   Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

2. Comfort [2 weeks]

   Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

3. Comfort [1-month]

   Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

4. Lens Preference Based on Overall Comfort [1 month]

   Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

5. Lens Preference Based on Overall Dryness [1 month]

   Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

6. Dryness [2 weeks]

   Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

7. Dryness [1-month]

   Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

Secondary Outcome Measures

1. Ease of Insertion [Dispense]

   Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

2. Ease of Insertion [2-weeks]

   Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

3. Ease of Insertion [1-month]

   Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

4. Ease of Removal [2-weeks]

   Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

5. Ease of Removal [1 month]

   Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Has had a self-reported oculo-visual examination in the last two years.

• Has read and signed an information consent letter;

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

• Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.

• Is willing to wear contact lens in both eyes for the duration of the study;

• Has a minimum astigmatism of - 0.75, determined by refraction;

• Can be fit with the two study contact lens types in the powers available;

• Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;

• Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.

• Has clear corneas and no active* ocular disease

Exclusion Criteria:

• Is participating in any concurrent clinical trial;

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

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

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

• Has known sensitivity to fluorescein dye or products to be used in the study;

• Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

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

• Is aphakic;

• Has undergone refractive error surgery.

• Has participated in the PIANO (i.e. EX-MKTG-83) Study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom, Director, Centre for Ocular Research & Education

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 14, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03519932
• Other Study ID Numbers: EX-MKTG-91
• First Posted: May 9, 2018
• Last Update Posted: Jan 6, 2020
• Last Verified: Dec 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: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.

Arm/Group Title	Comfilcon A Toric Then Samfilcon A Toric	Samfilcon A Toric Then Comfilcon A Toric
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month. Contact Lens: comfilcon A toric Contact Lens: Samfilcon A toric	Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month. Contact Lens: Samfilcon A toric Contact Lens: comfilcon A toric
Period Title: First Intervention
STARTED	24	25
COMPLETED	23	22
NOT COMPLETED	1	3
Period Title: First Intervention
STARTED	22	23
COMPLETED	22	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	49 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.5 (8.7)
Sex: Female, Male (Count of Participants)
Female	40 81.6%
Male	9 18.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	49 100%

Outcome Measures

1. Primary Outcome

Title	Comfort at Insertion
Description	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	9.0 (1.2)	8.8 (1.2)

2. Primary Outcome

Title	Comfort
Description	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	44	45
Overall	8.1 (1.4)	7.4 (2.1)
Removal	7.2 (2.1)	6.5 (2.4)

3. Primary Outcome

Title	Comfort
Description	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame	1-month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	44
Overall	8.1 (1.6)	7.4 (2.1)
Removal	7.1 (2.1)	6.7 (2.5)

4. Primary Outcome

Title	Lens Preference Based on Overall Comfort
Description	Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Percentages may be rounded and therefore may not add up to equal to 100%

Arm/Group Title	Overall Preference
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month. comfilcon A toric lens: Contact lens samfilcon A toric lens: Contact lens
Measure Participants	45
Strongly prefer comfilcon A	44 89.8%
Slightly Prefer comfilcon A	27 55.1%
No Preference	7 14.3%
Slightly prefer samfilcon A	7 14.3%
Strongly prefer samfilcon A	16 32.7%

5. Primary Outcome

Title	Lens Preference Based on Overall Dryness
Description	Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Participants
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month. comfilcon A toric lens: Contact lens samfilcon A toric lens: Contact lens
Measure Participants	45
Strongly prefer comfilcon A	29 59.2%
Slightly prefer comfilcon A	33 67.3%
No Preference	16 32.7%
Slightly prefer samfilcon A	4 8.2%
Strongly prefer samfilcon A	18 36.7%

6. Primary Outcome

Title	Dryness
Description	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	44	45
Overall	7.4 (2.0)	6.9 (2.2)
Removal	6.5 (2.5)	6.0 (2.3)

7. Primary Outcome

Title	Dryness
Description	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time Frame	1-month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	45
Overall	7.5 (1.8)	6.7 (2.5)
Removal	6.6 (2.3)	6.2 (2.6)

8. Secondary Outcome

Title	Ease of Insertion
Description	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	9.3 (1.0)	9.3 (0.9)

9. Secondary Outcome

Title	Ease of Insertion
Description	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	44	45
Mean (Standard Deviation) [units on a scale]	8.9 (1.5)	8.4 (1.9)

10. Secondary Outcome

Title	Ease of Insertion
Description	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame	1-month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	9.0 (1.4)	8.3 (1.8)

11. Secondary Outcome

Title	Ease of Removal
Description	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study. comfilcon A toric lens: Contact lens samfilcon A toric lens: Contact lens	Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study. comfilcon A toric lens: Contact lens samfilcon A toric lens: Contact lens
Measure Participants	44	45
Mean (Standard Deviation) [units on a scale]	7.9 (2.5)	8.4 (1.8)

12. Secondary Outcome

Title	Ease of Removal
Description	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Toric Lens	Samfilcon A Toric Lens
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	8.0 (2.4)	8.5 (1.7)

Adverse Events

Time Frame	One month during each crossover period.
Arm/Group Title	Comfilcon A Toric		Samfilcon A Toric
Arm/Group Description	Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study. Contact Lens: comfilcon A toric		Subjects were randomized to wear samfilcon A toric lenses for 1-month and comfilcon A toric lenses for 1-month in this cross-over dispensing study. Contact Lens: samfilcon A toric
All Cause Mortality
	Comfilcon A Toric		Samfilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	Comfilcon A Toric		Samfilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A Toric		Samfilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	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.

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.