Trial Outcomes & Findings for A Clinical Comparison of Three Soft Daily Disposable Contact Lenses (NCT NCT02920983)
NCT ID: NCT02920983
Last Updated: 2019-10-17
Results Overview
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
1 week
Results posted on
2019-10-17
Participant Flow
55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.
Subjects are randomized to wear each lens brand for one week in a random sequence.
Participant milestones
| Measure |
Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2
Subjects are randomized to wear somofilcon A pair of lenses for one week during the crossover study then nelfilcon A II2, then omafilcon A II 2 lenses for one week each.
|
Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2
Subjects are randomized to wear somofilcon A pair of lenses for one week during the cross-over study then omafilcon A II 2, then nelfilcon A II 2 lenses for one week each.
|
Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2
Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then Omafilcon A II 2 lenses for one week each.
|
Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A
Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Omafilcon A II 2, then Somofilcon A, lenses for one week each.
|
Omafilcon A II 2, Nelficon A II 2, Somofilcon A
Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then nelfilcon A II 2, then Somofilcon A lenses for one week each.
|
Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then nelfilcon A II 2 lenses for one week each.
|
|---|---|---|---|---|---|---|
|
Dispense 1
STARTED
|
8
|
10
|
7
|
6
|
13
|
7
|
|
Dispense 1
COMPLETED
|
8
|
10
|
7
|
6
|
12
|
7
|
|
Dispense 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dispense 2
STARTED
|
8
|
10
|
7
|
6
|
13
|
7
|
|
Dispense 2
COMPLETED
|
7
|
10
|
7
|
6
|
12
|
7
|
|
Dispense 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Dispense 3
STARTED
|
8
|
10
|
7
|
6
|
13
|
7
|
|
Dispense 3
COMPLETED
|
7
|
9
|
7
|
6
|
12
|
7
|
|
Dispense 3
NOT COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2
Subjects are randomized to wear somofilcon A pair of lenses for one week during the crossover study then nelfilcon A II2, then omafilcon A II 2 lenses for one week each.
|
Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2
Subjects are randomized to wear somofilcon A pair of lenses for one week during the cross-over study then omafilcon A II 2, then nelfilcon A II 2 lenses for one week each.
|
Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2
Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then Omafilcon A II 2 lenses for one week each.
|
Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A
Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Omafilcon A II 2, then Somofilcon A, lenses for one week each.
|
Omafilcon A II 2, Nelficon A II 2, Somofilcon A
Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then nelfilcon A II 2, then Somofilcon A lenses for one week each.
|
Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then nelfilcon A II 2 lenses for one week each.
|
|---|---|---|---|---|---|---|
|
Dispense 1
Unacceptable Lens Fit
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dispense 2
Unscceptable lens fit
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Dispense 3
Unacceptable Lens Fit
|
1
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Study
n=55 Participants
Total participants
|
|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Ocular Physiology
Conjunctival Hyperemia
|
0.76 units on a scale
Standard Deviation 0.26
|
0.79 units on a scale
Standard Deviation 0.31
|
0.78 units on a scale
Standard Deviation 0.28
|
|
Ocular Physiology
Limbal Hyperaemia
|
0.63 units on a scale
Standard Deviation 0.24
|
0.66 units on a scale
Standard Deviation 0.30
|
0.65 units on a scale
Standard Deviation 0.28
|
|
Ocular Physiology
Corneal Vascularization
|
0.05 units on a scale
Standard Deviation 0.11
|
0.05 units on a scale
Standard Deviation 0.10
|
0.06 units on a scale
Standard Deviation 0.09
|
|
Ocular Physiology
Microcysts
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Ocular Physiology
Oedema
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Ocular Physiology
Corneal Staining
|
0.33 units on a scale
Standard Deviation 0.42
|
0.42 units on a scale
Standard Deviation 0.43
|
0.26 units on a scale
Standard Deviation 0.36
|
|
Ocular Physiology
Conjunctival Staining
|
1.37 units on a scale
Standard Deviation 0.65
|
0.41 units on a scale
Standard Deviation 0.43
|
0.23 units on a scale
Standard Deviation 0.20
|
|
Ocular Physiology
Paipliiary Conjunctivitis
|
0.95 units on a scale
Standard Deviation 0.28
|
0.88 units on a scale
Standard Deviation 0.35
|
0.93 units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Fit - Horizontal Centration
Extremely Nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration
Slightly Nasal
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Lens Fit - Horizontal Centration
Optimum
|
28 Participants
|
28 Participants
|
26 Participants
|
|
Lens Fit - Horizontal Centration
Slightly Temporal
|
20 Participants
|
17 Participants
|
22 Participants
|
|
Lens Fit - Horizontal Centration
Extremely Temporal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Fit - Vertical Centration
Extremely Nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Vertical Centration
Slightly Nasal
|
11 Participants
|
20 Participants
|
22 Participants
|
|
Lens Fit - Vertical Centration
Optimum
|
21 Participants
|
22 Participants
|
22 Participants
|
|
Lens Fit - Vertical Centration
Slightly Temporal
|
17 Participants
|
6 Participants
|
5 Participants
|
|
Lens Fit - Vertical Centration
Extremely Temporal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Fit - Corneal Coverage
Extremely Nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Corneal Coverage
Slightly Nasal
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Lens Fit - Corneal Coverage
Optimum
|
46 Participants
|
39 Participants
|
41 Participants
|
|
Lens Fit - Corneal Coverage
Slightly Temporal
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Lens Fit - Corneal Coverage
Extremely Temporal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Fit - Movement
Extremely inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Movement
Slightly inadequate
|
3 Participants
|
19 Participants
|
12 Participants
|
|
Lens Fit - Movement
Optimum
|
38 Participants
|
27 Participants
|
27 Participants
|
|
Lens Fit - Movement
Slightly excessive
|
8 Participants
|
2 Participants
|
9 Participants
|
|
Lens Fit - Movement
Extremely excessive
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Surface - Deposition
Grade 0
|
46 Participants
|
47 Participants
|
48 Participants
|
|
Lens Surface - Deposition
Grade 1
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Lens Surface - Deposition
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Surface - Deposition
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Surface - Deposition
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Lens Surface - Wettability
Grade 0
|
37 Participants
|
44 Participants
|
43 Participants
|
|
Lens Surface - Wettability
Grade 1
|
9 Participants
|
3 Participants
|
3 Participants
|
|
Lens Surface - Wettability
Grade 2
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Lens Surface - Wettability
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Surface - Wettability
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Protocol deviations and discontinuations account for difference in analysis population
Visual acuity will be assessed by LogMAR.
Outcome measures
| Measure |
Somofilcon A
n=49 Participants
Subjects are randomized to wear somofilcon A for one week during the cross over study.
somofilcon A: contact lens
|
Nelfilcon A II 2
n=48 Participants
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
nelfilcon A II 2: contact lens
|
Omafilcon A ll 2
n=49 Participants
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
omafilcon A ll 2: contact lens
|
|---|---|---|---|
|
Visual Acuity
High Contrast
|
-0.11 LogMAR
Standard Deviation 0.08
|
-0.13 LogMAR
Standard Deviation 0.08
|
-0.11 LogMAR
Standard Deviation 0.07
|
|
Visual Acuity
Low Contrast
|
0.18 LogMAR
Standard Deviation 0.10
|
0.17 LogMAR
Standard Deviation 0.11
|
0.18 LogMAR
Standard Deviation 0.10
|
Adverse Events
Somofilcon A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nelfilcon A II 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Omafilcon A II 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Somofilcon A
n=49 participants at risk
Subjects are randomized to wear Somofilcon A for one week at random sequence
|
Nelfilcon A II 2
n=48 participants at risk
Subjects are randomized to wear Nelfilcon A II 2 for one week at random sequence
|
Omafilcon A II 2
n=49 participants at risk
Subjects are randomized to wear Omafilcon A II 2 for one week at random sequence
|
|---|---|---|---|
|
Infections and infestations
Common cold
|
8.2%
4/49 • Number of events 4 • Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.
|
6.2%
3/48 • Number of events 3 • Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.
|
8.2%
4/49 • Number of events 4 • Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place