Trial Outcomes & Findings for Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit (NCT NCT02588573)
NCT ID: NCT02588573
Last Updated: 2019-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
8 hours
Results posted on
2019-02-08
Participant Flow
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.
Unit of analysis: eyes
Participant milestones
| Measure |
Habitual Etafilcon A Wearers
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 FREQ Wearers
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45 90
|
45 90
|
|
Overall Study
Randomized Eye Etafilcon A
|
45 45
|
45 45
|
|
Overall Study
Randomized Eye Somofilcon A
|
45 45
|
45 45
|
|
Overall Study
COMPLETED
|
45 90
|
45 90
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Baseline characteristics by cohort
| Measure |
Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A
n=45 Participants
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 FREQ Wearers Wearing Etafilcon A/Somofilcon A
n=45 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursSubjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 eyes
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 eyes
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 FREQ Wearers Randomized to Etafilcon A
n=45 eyes
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 FREQ Wearers Randomized to Somofilcon A
n=45 eyes
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
|
|---|---|---|---|---|
|
Comfort
|
83 units on a scale
Standard Deviation 17
|
77 units on a scale
Standard Deviation 22
|
83 units on a scale
Standard Deviation 14
|
83 units on a scale
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Baseline and 8 hoursLens 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
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 Participants
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 Participants
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 FREQ Wearers Randomized to Etafilcon A
n=45 Participants
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 FREQ Wearers Randomized to Somofilcon A
n=45 Participants
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
|
|---|---|---|---|---|
|
Comfort Preference
Strongly Prefer Etafilcon A Lens
|
7 participants
|
3 participants
|
13 participants
|
2 participants
|
|
Comfort Preference
Slightly Prefer Etafilcon A Lens
|
14 participants
|
10 participants
|
11 participants
|
16 participants
|
|
Comfort Preference
No Preference
|
12 participants
|
19 participants
|
5 participants
|
10 participants
|
|
Comfort Preference
Slightly Prefer Somofilcon A Lens
|
10 participants
|
11 participants
|
9 participants
|
8 participants
|
|
Comfort Preference
Strongly Prefer Somofilcon A Lens
|
2 participants
|
2 participants
|
7 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Baseline and 8 hoursBulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 eyes
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 eyes
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 FREQ Wearers Randomized to Etafilcon A
n=45 eyes
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 FREQ Wearers Randomized to Somofilcon A
n=45 eyes
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
|
|---|---|---|---|---|
|
Bulbar Hyperemia
Baseline
|
1.3 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.4
|
1.2 units on a scale
Standard Deviation 0.4
|
1.2 units on a scale
Standard Deviation 0.4
|
|
Bulbar Hyperemia
8 hours
|
1.3 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.4
|
1.2 units on a scale
Standard Deviation 0.4
|
1.2 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline and 8 hoursLimbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 eyes
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 eyes
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 FREQ Wearers Randomized to Etafilcon A
n=45 eyes
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 FREQ Wearers Randomized to Somofilcon A
n=45 eyes
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
|
|---|---|---|---|---|
|
Limbal Hyperemia
Baseline
|
1.2 units on a scale
Standard Deviation 0.5
|
1.2 units on a scale
Standard Deviation 0.5
|
1.0 units on a scale
Standard Deviation 0.4
|
1.0 units on a scale
Standard Deviation 0.4
|
|
Limbal Hyperemia
8 hours
|
1.2 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.4
|
1.4 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 8 hoursConjunctival 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
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 eyes
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 eyes
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 FREQ Wearers Randomized to Etafilcon A
n=45 eyes
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 FREQ Wearers Randomized to Somofilcon A
n=45 eyes
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
|
|---|---|---|---|---|
|
Conjunctival Staining
Nasal
|
1.0 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 1.0
|
1.1 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Conjunctival Staining
Temporal
|
0.4 units on a scale
Standard Deviation 0.5
|
1.1 units on a scale
Standard Deviation 0.9
|
0.6 units on a scale
Standard Deviation 0.6
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Conjunctival Staining
Superior
|
0.3 units on a scale
Standard Deviation 0.5
|
0.6 units on a scale
Standard Deviation 0.8
|
0.2 units on a scale
Standard Deviation 0.5
|
0.9 units on a scale
Standard Deviation 0.8
|
|
Conjunctival Staining
Inferior
|
0.6 units on a scale
Standard Deviation 0.7
|
1.1 units on a scale
Standard Deviation 1.0
|
0.6 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Baseline and 8 hoursHigh contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Outcome measures
| Measure |
Habitual Etafilcon A Wearers Randomized to Etafilcon A
n=45 eyes
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 Etafilcon A Wearers Randomized to Somofilcon A
n=45 eyes
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 FREQ Wearers Randomized to Etafilcon A
n=45 eyes
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 FREQ Wearers Randomized to Somofilcon A
n=45 eyes
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
|
|---|---|---|---|---|
|
Visual Acuity
Baseline
|
-0.05 LogMAR
Standard Deviation 0.07
|
-0.05 LogMAR
Standard Deviation 0.09
|
-0.07 LogMAR
Standard Deviation 0.06
|
-0.06 LogMAR
Standard Deviation 0.08
|
|
Visual Acuity
8 hours
|
-0.06 LogMAR
Standard Deviation 0.08
|
-0.06 LogMAR
Standard Deviation 0.10
|
-0.07 LogMAR
Standard Deviation 0.08
|
-0.06 LogMAR
Standard Deviation 0.08
|
Adverse Events
Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Etafilcon A Lens (Control) Worn by Habitual FREQ Grp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Somofilcon A Lens (Test) Worn by Habitual FREQ Grp
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
Senior Manager Global Medical Scientific Affairs
CooperVision Inc.
Phone: 925 621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER