Evaluation of Stenfilcon A Versus Etafilcon A

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01809834
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

Evaluation of two contact lenses

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Etafilcon A; Device: Stenfilcon A	N/A

Detailed Description

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Evaluation of Stenfilcon A Versus Etafilcon A
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Etafilcon A Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously	Device: Stenfilcon A
Experimental: Stenfilcon A Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously	Device: Etafilcon A

Outcome Measures

Primary Outcome Measures

1. Participant's Subjective Rating of Comfort (Questionnaire) [Insertion, After Lens settling, 12-hours, 1-week]

   Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week

2. Participant's Subjective Rating of Dryness (Questionnaire) [12-hours, 1-week]

   Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week

3. Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) [Dispense]

   Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing

4. Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) [12-hours, 1-week]

   Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week

5. Participant's Subjective Rating of Visual Quality (Questionnaire) [12-hours, 1-week]

   Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week

6. Participant's Subjective Rating of Overall Preference (Questionnaire) [12-hours, 1-week]

   Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week

Secondary Outcome Measures

1. Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) [Insertion, 12 hours, 1 week]

   Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).

2. Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) [Insertion, 12 hours, 1 week]

   Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week

3. Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) [Insertion]

   Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.

4. Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) [Insertion, 12-hours, 1-week]

   Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.

5. Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) [Baseline, 12-hours, 1-week]

   Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week

6. Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) [Baseline, 12-hours, 1-week]

   Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week

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 read and signed an information consent letter;

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

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

• Has astigmatism less than or equal to -1.00D;

• Is an adapted soft contact lens wearer;

• Demonstrates an acceptable fit with the study lenses;

• Has no active anterior segment disease or known ocular disease.

Exclusion Criteria:

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

• Has never worn contact lenses before;

• Has any systemic disease affecting ocular health;

• Is using any systemic or topical medications that will affect ocular health;

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;

• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;

• Is aphakic;

• Has undergone corneal refractive surgery;

• Is participating in any other type of clinical or research study;

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

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

• Principal Investigator: Lyndon Jones, PhD., FCO, Univeristy of Waterloo, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01809834
• Other Study ID Numbers: CV-12-57
• First Posted: Mar 13, 2013
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Two participants were determined to be ineligible at the screening visit due to their level of astigmatism

Arm/Group Title	All Participants
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously Etafilcon A Stenfilcon A
Period Title: Overall Study
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Overall Participants	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.9 (9.5)
Age (Count of Participants)
<=18 years	1 2.3%
Between 18 and 65 years	43 97.7%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	33 75%
Male	11 25%
Region of Enrollment (participants) [Number]
Canada	44 100%

Outcome Measures

1. Primary Outcome

Title	Participant's Subjective Rating of Comfort (Questionnaire)
Description	Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Time Frame	Insertion, After Lens settling, 12-hours, 1-week

Outcome Measure Data

Analysis Population Description

One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Insertion	92 (11)	91 (11)
After settling	96 (7)	93 (10)
12-hours	91 (12)	88 (13)
1-week	90 (10)	90 (10)

2. Secondary Outcome

Title	Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Description	Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).
Time Frame	Insertion, 12 hours, 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Insertion	0.69 (0.82)	0.78 (0.89)
12-hours	1.51 (1.26)	1.47 (1.16)
1-week	1.06 (1.00)	1.15 (0.98)

3. Secondary Outcome

Title	Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Description	Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week
Time Frame	Insertion, 12 hours, 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Insertion	3.37 (0.47)	3.44 (0.42)
12-hours	3.26 (0.47)	3.40 (0.37)
1-week	3.36 (0.40)	3.48 (0.31)

4. Primary Outcome

Title	Participant's Subjective Rating of Dryness (Questionnaire)
Description	Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Time Frame	12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
12-hours	86 (17)	83 (21)
1-week	83 (20)	82 (21)

5. Primary Outcome

Title	Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Description	Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Mean (Standard Deviation) [score on a scale]	80 (19)	86 (14)

6. Primary Outcome

Title	Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Description	Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Time Frame	12-hours, 1-week

Outcome Measure Data

Analysis Population Description

One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
12-hours	97 (7)	92 (15)
1-week	94 (12)	94 (9)

7. Primary Outcome

Title	Participant's Subjective Rating of Visual Quality (Questionnaire)
Description	Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Time Frame	12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
12-hours	92 (13)	89 (15)
1-week	89 (12)	89 (14)

8. Primary Outcome

Title	Participant's Subjective Rating of Overall Preference (Questionnaire)
Description	Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week
Time Frame	12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44
12-hours	-8 (24)
1-week	5 (16)

9. Secondary Outcome

Title	Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Description	Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time Frame	Insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Insertion	-0.09 (0.09)	-0.08 (0.08)
12-hours	-0.09 (0.07)	-0.08 (0.07)
1-week	-0.09 (0.06)	-0.08 (0.07)

10. Secondary Outcome

Title	Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Description	Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time Frame	Insertion, 12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
Insertion	-0.07 (0.08)	-0.06 (0.07)
12-hours	-0.07 (0.07)	-0.07 (0.07)
1-week	-0.08 (0.07)	-0.07 (0.07)

11. Secondary Outcome

Title	Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Description	Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time Frame	Baseline, 12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
baseline Central	0.08 (0.28)	0.23 (0.48)
baseline Nasal	0.47 (0.67)	0.56 (0.74)
baseline Temporal	0.23 (0.61)	0.14 (0.38)
baseline Superior	0.30 (0.60)	0.25 (0.51)
baseline Inferior	0.70 (0.97)	0.55 (0.70)
12-hours Central	0.08 (0.26)	0.16 (0.44)
12-hours Nasal	0.09 (0.31)	0.32 (0.66)
12-hours Temporal	0.24 (0.61)	0.16 (0.40)
12-hours Superior	0.23 (0.45)	0.32 (0.51)
12-hours Inferior	0.68 (0.89)	0.74 (0.87)
1-week Central	0.10 (0.35)	0.12 (0.39)
1-week Nasal	0.23 (0.51)	0.24 (0.48)
1-week Temporal	0.22 (0.51)	0.16 (0.41)
1-week Superior	0.17 (0.44)	0.23 (0.54)
1-week Inferior	0.69 (0.74)	0.51 (0.82)

12. Secondary Outcome

Title	Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Description	Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time Frame	Baseline, 12-hours, 1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Stenfilcon A
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Etafilcon A Stenfilcon A
Measure Participants	44	44
Measure eyes	44	44
baseline Nasal	0.23 (.035)	0.21 (0.38)
baseline Temporal	0.15 (0.25)	0.11 (0.21)
baseline Superior	0.06 (0.19)	0.06 (0.19)
baseline Inferior	0.09 (0.29)	0.08 (0.26)
12-hours Nasal	0.86 (0.73)	0.72 (0.57)
12-hours Temporal	0.55 (0.55)	0.93 (0.59)
12-hours Superior	0.17 (0.24)	0.59 (0.73)
12-hours Inferior	0.63 (0.74)	0.76 (0.68)
1-week Nasal	0.83 (0.62)	0.52 (0.56)
1-week Temporal	0.34 (0.41)	0.55 (0.57)
1-week Superior	0.17 (0.30)	0.33 (0.44)
1-week Inferior	0.65 (0.85)	0.50 (0.66)

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Each participant was randomized to wear the test lens in one eye and the control lens in the other Etafilcon A Stenfilcon A
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/44 (0%)

Limitations/Caveats

One participant temporarily discontinued after 12-hour visit. (Primary outcome 1 and 4,1-week visit, n=43)

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.