Trial Outcomes & Findings for Evaluation of Stenfilcon A Versus Etafilcon A (NCT NCT01809834)
NCT ID: NCT01809834
Last Updated: 2020-07-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Insertion, After Lens settling, 12-hours, 1-week
Results posted on
2020-07-28
Participant Flow
Two participants were determined to be ineligible at the screening visit due to their level of astigmatism
Participant milestones
| Measure |
All Participants
Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously
Etafilcon A
Stenfilcon A
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Stenfilcon A Versus Etafilcon A
Baseline characteristics by cohort
| Measure |
All Participants
n=44 Participants
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Insertion, After Lens settling, 12-hours, 1-weekPopulation: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)
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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Participant's Subjective Rating of Comfort (Questionnaire)
Insertion
|
92 units on a scale
Standard Deviation 11
|
91 units on a scale
Standard Deviation 11
|
|
Participant's Subjective Rating of Comfort (Questionnaire)
After settling
|
96 units on a scale
Standard Deviation 7
|
93 units on a scale
Standard Deviation 10
|
|
Participant's Subjective Rating of Comfort (Questionnaire)
12-hours
|
91 units on a scale
Standard Deviation 12
|
88 units on a scale
Standard Deviation 13
|
|
Participant's Subjective Rating of Comfort (Questionnaire)
1-week
|
90 units on a scale
Standard Deviation 10
|
90 units on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 12-hours, 1-weekParticipants 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Participant's Subjective Rating of Dryness (Questionnaire)
12-hours
|
86 units on a scale
Standard Deviation 17
|
83 units on a scale
Standard Deviation 21
|
|
Participant's Subjective Rating of Dryness (Questionnaire)
1-week
|
83 units on a scale
Standard Deviation 20
|
82 units on a scale
Standard Deviation 21
|
PRIMARY outcome
Timeframe: DispenseParticipants 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
|
80 score on a scale
Standard Deviation 19
|
86 score on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: 12-hours, 1-weekPopulation: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)
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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
12-hours
|
97 units on a scale
Standard Deviation 7
|
92 units on a scale
Standard Deviation 15
|
|
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
1-week
|
94 units on a scale
Standard Deviation 12
|
94 units on a scale
Standard Deviation 9
|
PRIMARY outcome
Timeframe: 12-hours, 1-weekParticipants 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Participant's Subjective Rating of Visual Quality (Questionnaire)
12-hours
|
92 units on a scale
Standard Deviation 13
|
89 units on a scale
Standard Deviation 15
|
|
Participant's Subjective Rating of Visual Quality (Questionnaire)
1-week
|
89 units on a scale
Standard Deviation 12
|
89 units on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: 12-hours, 1-weekParticipants 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
Outcome measures
| Measure |
Etafilcon A
n=44 Participants
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon 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
|
|---|---|---|
|
Participant's Subjective Rating of Overall Preference (Questionnaire)
1-week
|
5 score on a scale
Standard Deviation 16
|
—
|
|
Participant's Subjective Rating of Overall Preference (Questionnaire)
12-hours
|
-8 score on a scale
Standard Deviation 24
|
—
|
SECONDARY outcome
Timeframe: Insertion, 12 hours, 1 weekInvestigators 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).
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Insertion
|
0.69 units on a scale
Standard Deviation 0.82
|
0.78 units on a scale
Standard Deviation 0.89
|
|
Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
12-hours
|
1.51 units on a scale
Standard Deviation 1.26
|
1.47 units on a scale
Standard Deviation 1.16
|
|
Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
1-week
|
1.06 units on a scale
Standard Deviation 1.00
|
1.15 units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Insertion, 12 hours, 1 weekInvestigators 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
1-week
|
3.36 units on a scale
Standard Deviation 0.40
|
3.48 units on a scale
Standard Deviation 0.31
|
|
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Insertion
|
3.37 units on a scale
Standard Deviation 0.47
|
3.44 units on a scale
Standard Deviation 0.42
|
|
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
12-hours
|
3.26 units on a scale
Standard Deviation 0.47
|
3.40 units on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: InsertionInvestigators 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.
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Insertion
|
-0.09 logMAR
Standard Deviation 0.09
|
-0.08 logMAR
Standard Deviation 0.08
|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
12-hours
|
-0.09 logMAR
Standard Deviation 0.07
|
-0.08 logMAR
Standard Deviation 0.07
|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
1-week
|
-0.09 logMAR
Standard Deviation 0.06
|
-0.08 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Insertion, 12-hours, 1-weekInvestigators 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.
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Insertion
|
-0.07 logMAR
Standard Deviation 0.08
|
-0.06 logMAR
Standard Deviation 0.07
|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
12-hours
|
-0.07 logMAR
Standard Deviation 0.07
|
-0.07 logMAR
Standard Deviation 0.07
|
|
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
1-week
|
-0.08 logMAR
Standard Deviation 0.07
|
-0.07 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, 12-hours, 1-weekInvestigators 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
baseline Central
|
0.08 units on a scale
Standard Deviation 0.28
|
0.23 units on a scale
Standard Deviation 0.48
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
baseline Nasal
|
0.47 units on a scale
Standard Deviation 0.67
|
0.56 units on a scale
Standard Deviation 0.74
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
baseline Temporal
|
0.23 units on a scale
Standard Deviation 0.61
|
0.14 units on a scale
Standard Deviation 0.38
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
baseline Superior
|
0.30 units on a scale
Standard Deviation 0.60
|
0.25 units on a scale
Standard Deviation 0.51
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
baseline Inferior
|
0.70 units on a scale
Standard Deviation 0.97
|
0.55 units on a scale
Standard Deviation 0.70
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
12-hours Central
|
0.08 units on a scale
Standard Deviation 0.26
|
0.16 units on a scale
Standard Deviation 0.44
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
12-hours Nasal
|
0.09 units on a scale
Standard Deviation 0.31
|
0.32 units on a scale
Standard Deviation 0.66
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
12-hours Temporal
|
0.24 units on a scale
Standard Deviation 0.61
|
0.16 units on a scale
Standard Deviation 0.40
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
12-hours Superior
|
0.23 units on a scale
Standard Deviation 0.45
|
0.32 units on a scale
Standard Deviation 0.51
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
12-hours Inferior
|
0.68 units on a scale
Standard Deviation 0.89
|
0.74 units on a scale
Standard Deviation 0.87
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
1-week Central
|
0.10 units on a scale
Standard Deviation 0.35
|
0.12 units on a scale
Standard Deviation 0.39
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
1-week Nasal
|
0.23 units on a scale
Standard Deviation 0.51
|
0.24 units on a scale
Standard Deviation 0.48
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
1-week Temporal
|
0.22 units on a scale
Standard Deviation 0.51
|
0.16 units on a scale
Standard Deviation 0.41
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
1-week Superior
|
0.17 units on a scale
Standard Deviation 0.44
|
0.23 units on a scale
Standard Deviation 0.54
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
1-week Inferior
|
0.69 units on a scale
Standard Deviation 0.74
|
0.51 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, 12-hours, 1-weekInvestigators 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
Outcome measures
| Measure |
Etafilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
Stenfilcon A
n=44 eyes
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A
|
|---|---|---|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
baseline Nasal
|
0.23 units on a scale
Standard Deviation .035
|
0.21 units on a scale
Standard Deviation 0.38
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
baseline Temporal
|
0.15 units on a scale
Standard Deviation 0.25
|
0.11 units on a scale
Standard Deviation 0.21
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
baseline Superior
|
0.06 units on a scale
Standard Deviation 0.19
|
0.06 units on a scale
Standard Deviation 0.19
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
baseline Inferior
|
0.09 units on a scale
Standard Deviation 0.29
|
0.08 units on a scale
Standard Deviation 0.26
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
12-hours Nasal
|
0.86 units on a scale
Standard Deviation 0.73
|
0.72 units on a scale
Standard Deviation 0.57
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
12-hours Temporal
|
0.55 units on a scale
Standard Deviation 0.55
|
0.93 units on a scale
Standard Deviation 0.59
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
12-hours Superior
|
0.17 units on a scale
Standard Deviation 0.24
|
0.59 units on a scale
Standard Deviation 0.73
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
12-hours Inferior
|
0.63 units on a scale
Standard Deviation 0.74
|
0.76 units on a scale
Standard Deviation 0.68
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
1-week Nasal
|
0.83 units on a scale
Standard Deviation 0.62
|
0.52 units on a scale
Standard Deviation 0.56
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
1-week Temporal
|
0.34 units on a scale
Standard Deviation 0.41
|
0.55 units on a scale
Standard Deviation 0.57
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
1-week Superior
|
0.17 units on a scale
Standard Deviation 0.30
|
0.33 units on a scale
Standard Deviation 0.44
|
|
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
1-week Inferior
|
0.65 units on a scale
Standard Deviation 0.85
|
0.50 units on a scale
Standard Deviation 0.66
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lyndon Jones, PhD, FCO
School of Optometry, University of Waterloo
Phone: 519-888-4742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60