Trial Outcomes & Findings for Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses (NCT NCT03098745)
NCT ID: NCT03098745
Last Updated: 2019-04-09
Results Overview
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline (lens insertion), 1 hour
Results posted on
2019-04-09
Participant Flow
Participant milestones
| Measure |
Omafilcon A, Omafilcon A - Proclear (PC), Somofilcon A
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then Somofilcon A lens pair bilaterally for 1 hour.
|
Omafilcon A, Somofilcon A, Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then Somofilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour.
|
Somofilcon A, Omafilcon A - Proclear (PC), Omafilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then omafilcon A lens pair bilaterally for 1 hour.
|
Somofilcon A, Omafilcon A, Omafilcon A- Proclear (PC)
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour.
|
Omafilcon A - Proclear (PC), Omafilcon A, Somofilcon A
Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then somofilcon A lens pair bilaterally for 1 hour.
|
Omafilcon A - Proclear (PC), Somofilcon A, Omafilcon A
Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then somofilcon A, then omafilcon A lens pair bilaterally for 1 hour.
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|---|---|---|---|---|---|---|
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Day 1
STARTED
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7
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3
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8
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8
|
10
|
4
|
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Day 1
COMPLETED
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7
|
3
|
8
|
8
|
10
|
4
|
|
Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
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0
|
0
|
|
Day 2
STARTED
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7
|
3
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8
|
8
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10
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4
|
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Day 2
COMPLETED
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7
|
3
|
8
|
8
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10
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4
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Day 2
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Day 3
STARTED
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7
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3
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8
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8
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10
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4
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Day 3
COMPLETED
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7
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3
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8
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8
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10
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4
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Day 3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=40 Participants
Participants are randomized to wear omafilcon A lens pair, Somofilcon A lens pair, Omafilcon A - Proclear PC bilaterally for 1 hour during the study on separate days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 6.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=40 Participants
|
|
Region of Enrollment
Mexico
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (lens insertion), 1 hourHigh contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Visual Acuity
Lens Insertion (CL)
|
-0.04 logMAR
Standard Deviation 0.05
|
-0.05 logMAR
Standard Deviation 0.05
|
-0.03 logMAR
Standard Deviation 0.04
|
|
Visual Acuity
1 Hour (Specs)
|
-0.01 logMAR
Standard Deviation 0.03
|
-0.01 logMAR
Standard Deviation 0.03
|
-0.01 logMAR
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Insertion, 1hrSubjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Comfort
Insertion
|
94.5 units on a scale
Standard Deviation 8.5
|
98.0 units on a scale
Standard Deviation 5.0
|
94.7 units on a scale
Standard Deviation 7.4
|
|
Comfort
1 Hour
|
95.8 units on a scale
Standard Deviation 8.2
|
96.8 units on a scale
Standard Deviation 5.5
|
93.7 units on a scale
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: InsertionCentration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Lens Centration
Optimum
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Lens Centration
Decentration Acceptable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Centration
Decentration Unacceptable
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 HourCentration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Lens Centration
Optimum
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Lens Centration
Decentration Acceptable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Centration
Decentration Unacceptable
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: InsertionAmount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Post-blink Lens Movement
Insufficient
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Post-blink Lens Movement
Minimum
|
9 Participants
|
1 Participants
|
7 Participants
|
|
Post-blink Lens Movement
Optimum
|
27 Participants
|
31 Participants
|
19 Participants
|
|
Post-blink Lens Movement
Moderate
|
3 Participants
|
8 Participants
|
13 Participants
|
|
Post-blink Lens Movement
Excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 HourAmount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Post-blink Lens Movement
Insufficient
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Post-blink Lens Movement
Minimum
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Post-blink Lens Movement
Optimum
|
31 Participants
|
37 Participants
|
34 Participants
|
|
Post-blink Lens Movement
Moderate
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Post-blink Lens Movement
Excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: InsertionInvestigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Lens Fit Acceptance
Shouldn't be worn
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Lens Fit Acceptance
Borderline
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Lens Fit Acceptance
Min acceptable
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Lens Fit Acceptance
OK to dispense
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Lens Fit Acceptance
Perfect
|
26 Participants
|
29 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 1 HourInvestigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Lens Fit Acceptance
Shouldn't be worn
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Lens Fit Acceptance
Borderline
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Lens Fit Acceptance
Min acceptable
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Lens Fit Acceptance
OK to dispense
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Lens Fit Acceptance
Perfect
|
30 Participants
|
35 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 1 HourInvestigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Lens Fit Preference
omafilcon A
|
5 Participants
|
—
|
—
|
|
Lens Fit Preference
somofilcon A
|
2 Participants
|
—
|
—
|
|
Lens Fit Preference
omafilcon A - Proclear (PC)
|
6 Participants
|
—
|
—
|
|
Lens Fit Preference
No Preference
|
27 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 HourRedness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Limbal Redness
|
0.41 units on a scale
Standard Deviation 0.3
|
0.39 units on a scale
Standard Deviation 0.3
|
0.39 units on a scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 1 HourRedness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A: contact lens
|
Somofilcon A
n=40 Participants
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A: contact lens
|
Omafilcon A - Proclear (PC)
n=40 Participants
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC): contact lens
|
|---|---|---|---|
|
Bulbar Redness
|
0.51 units on a scale
Standard Deviation 0.36
|
0.55 units on a scale
Standard Deviation 0.38
|
0.50 units on a scale
Standard Deviation 0.37
|
Adverse Events
Omafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Somofilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omafilcon A - Proclear (PC)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place