Trial Outcomes & Findings for Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses (NCT NCT03235115)
NCT ID: NCT03235115
Last Updated: 2019-09-12
Results Overview
Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Methafilcon A IV, Ocufilcon B, Omafilcon A
Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens
|
Methafilcon A IV, Omafilcon A, Ocufilcon B
Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens
|
Ocufilcon B, Omafilcon A, Methafilcon A IV
Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens
|
Ocufilcon B, Methafilcon A IV, Omafilcon A
Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens
|
Omafilcon A, Ocufilcon B, Methafilcon A IV
Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens
|
Omafilcon A, Methafilcon A IV, Ocufilcon B
Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Hour, Visit 2)
STARTED
|
9
|
6
|
7
|
6
|
6
|
6
|
|
First Intervention (1 Hour, Visit 2)
COMPLETED
|
9
|
6
|
7
|
6
|
6
|
5
|
|
First Intervention (1 Hour, Visit 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Intervention (1 Hour, Visit 4)
STARTED
|
9
|
6
|
7
|
6
|
6
|
5
|
|
Second Intervention (1 Hour, Visit 4)
COMPLETED
|
9
|
6
|
7
|
6
|
6
|
5
|
|
Second Intervention (1 Hour, Visit 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention ( 1 Hour, Visit 6)
STARTED
|
9
|
6
|
7
|
6
|
6
|
5
|
|
Third Intervention ( 1 Hour, Visit 6)
COMPLETED
|
9
|
6
|
7
|
6
|
6
|
5
|
|
Third Intervention ( 1 Hour, Visit 6)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Methafilcon A IV, Ocufilcon B, Omafilcon A
Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens
|
Methafilcon A IV, Omafilcon A, Ocufilcon B
Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens
|
Ocufilcon B, Omafilcon A, Methafilcon A IV
Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens
|
Ocufilcon B, Methafilcon A IV, Omafilcon A
Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens
|
Omafilcon A, Ocufilcon B, Methafilcon A IV
Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens
|
Omafilcon A, Methafilcon A IV, Ocufilcon B
Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Hour, Visit 2)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=40 Participants
All study participants were randomized to wear each of the 3 different contact lens pairs
|
|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 6.4 • n=40 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type wornAssessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Subjects who wore Omafilcon A for 1 hour during the cross over study.
|
Methafilcon A IV
n=39 Participants
Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
|
Ocufilcon B
n=39 Participants
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
|
|---|---|---|---|
|
Visual Acuity Using logMAR
At Dispense
|
-0.14 logMAR
Standard Deviation 0.09
|
-0.13 logMAR
Standard Deviation 0.07
|
-0.13 logMAR
Standard Deviation 0.07
|
|
Visual Acuity Using logMAR
Follow Up
|
-0.14 logMAR
Standard Deviation 0.07
|
-0.14 logMAR
Standard Deviation 0.07
|
-0.14 logMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type wornAssessment of horizontal centration of lens on eye
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Subjects who wore Omafilcon A for 1 hour during the cross over study.
|
Methafilcon A IV
n=39 Participants
Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
|
Ocufilcon B
n=39 Participants
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
|
|---|---|---|---|
|
Lens Fit - Horizontal Centration
At dispense · Extremely nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration
At dispense · Slightly nasal
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Lens Fit - Horizontal Centration
At dispense · Optimum
|
23 Participants
|
17 Participants
|
26 Participants
|
|
Lens Fit - Horizontal Centration
At dispense · Slightly temporal
|
16 Participants
|
21 Participants
|
12 Participants
|
|
Lens Fit - Horizontal Centration
At dispense · Extremely temporal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration
At follow up · Extremely nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration
At follow up · Slightly nasal
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration
At follow up · Optimum
|
22 Participants
|
14 Participants
|
26 Participants
|
|
Lens Fit - Horizontal Centration
At follow up · Slightly temporal
|
17 Participants
|
22 Participants
|
13 Participants
|
|
Lens Fit - Horizontal Centration
At follow up · Extremely temporal
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type wornAssessment of vertical centration of lens on eye
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Subjects who wore Omafilcon A for 1 hour during the cross over study.
|
Methafilcon A IV
n=39 Participants
Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
|
Ocufilcon B
n=39 Participants
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
|
|---|---|---|---|
|
Lens Fit - Vertical Centration
At dispense · Extremely inferior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Vertical Centration
At dispense · Slightly inferior
|
12 Participants
|
6 Participants
|
9 Participants
|
|
Lens Fit - Vertical Centration
At dispense · Optimum
|
20 Participants
|
9 Participants
|
27 Participants
|
|
Lens Fit - Vertical Centration
At dispense · Slightly superior
|
8 Participants
|
24 Participants
|
3 Participants
|
|
Lens Fit - Vertical Centration
At dispense · Extremely superior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Vertical Centration
At follow up · Extremely inferior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Vertical Centration
At follow up · Slightly inferior
|
15 Participants
|
4 Participants
|
11 Participants
|
|
Lens Fit - Vertical Centration
At follow up · Optimum
|
18 Participants
|
14 Participants
|
26 Participants
|
|
Lens Fit - Vertical Centration
At follow up · Slightly superior
|
7 Participants
|
21 Participants
|
2 Participants
|
|
Lens Fit - Vertical Centration
At follow up · Extremely superior
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type wornAssessment of corneal coverage of lens on eye
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Subjects who wore Omafilcon A for 1 hour during the cross over study.
|
Methafilcon A IV
n=39 Participants
Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
|
Ocufilcon B
n=39 Participants
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
|
|---|---|---|---|
|
Lens Fit - Corneal Coverage of Lens
At dispense · Extremely inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At dispense · Slightly inadequate
|
6 Participants
|
16 Participants
|
4 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At dispense · Optimum
|
29 Participants
|
22 Participants
|
30 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At dispense · Slightly excessive
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At dispense · Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At follow up · Extremely inadequate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At follow up · Slightly inadequate
|
5 Participants
|
13 Participants
|
4 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At follow up · Optimum
|
30 Participants
|
24 Participants
|
30 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At follow up · Slightly excessive
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Lens Fit - Corneal Coverage of Lens
At follow up · Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type wornAssessment of movement of lens on eye
Outcome measures
| Measure |
Omafilcon A
n=40 Participants
Subjects who wore Omafilcon A for 1 hour during the cross over study.
|
Methafilcon A IV
n=39 Participants
Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
|
Ocufilcon B
n=39 Participants
Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
|
|---|---|---|---|
|
Lens Fit - Movement of Lens
At dispense · Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Movement of Lens
At follow up · Extremely inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Movement of Lens
At dispense · Extremely inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Lens Fit - Movement of Lens
At dispense · Slightly inadequate
|
1 Participants
|
7 Participants
|
8 Participants
|
|
Lens Fit - Movement of Lens
At dispense · Optimum
|
24 Participants
|
25 Participants
|
16 Participants
|
|
Lens Fit - Movement of Lens
At dispense · Slightly excessive
|
15 Participants
|
7 Participants
|
15 Participants
|
|
Lens Fit - Movement of Lens
At follow up · Slightly inadequate
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Lens Fit - Movement of Lens
At follow up · Optimum
|
23 Participants
|
28 Participants
|
19 Participants
|
|
Lens Fit - Movement of Lens
At follow up · Slightly excessive
|
15 Participants
|
9 Participants
|
19 Participants
|
|
Lens Fit - Movement of Lens
At follow up · Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Omafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methafilcon A IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ocufilcon B
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 Disclosure restriction on the PI is that the sponsor should be notified of any use of data for results communication.
- Publication restrictions are in place
Restriction type: OTHER