Trial Outcomes & Findings for Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear (NCT NCT02847169)
NCT ID: NCT02847169
Last Updated: 2017-05-08
Results Overview
Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 1 week
Results posted on
2017-05-08
Participant Flow
Participant milestones
| Measure |
Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens
Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens
|
Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens
Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
15
|
15
|
|
First Intervention (1 Week)
COMPLETED
|
15
|
15
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
15
|
15
|
|
Second Intervention (1 Week)
COMPLETED
|
15
|
15
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Baseline characteristics by cohort
| Measure |
Overall Participants
n=29 Participants
Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens
|
|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 weekInvestigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Overall Fit Acceptance
|
3.8 units on a scale
Standard Deviation 0.5
|
3.5 units on a scale
Standard Deviation 0.5
|
3.7 units on a scale
Standard Deviation 0.5
|
3.8 units on a scale
Standard Deviation 0.4
|
3.7 units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Baseline and 1 weekLens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Lens Centration
Baseline - filcon IV1 toric
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Lens Centration
Baseline - ocufilcon D toric
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Lens Centration
Habitual toric lens
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Lens Centration
1 week - filcon IV1 toric
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Lens Centration
1 week - ocufilcon D toric
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPost-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Post-blink Movement
|
1.97 units on a scale
Standard Deviation 0.5
|
2.1 units on a scale
Standard Deviation 0.3
|
2.1 units on a scale
Standard Deviation 0.4
|
2.0 units on a scale
Standard Deviation 0.3
|
2.2 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline and 1 weekOverall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Overall Stability
|
3.8 units on a scale
Standard Deviation 0.5
|
3.6 units on a scale
Standard Deviation 0.5
|
3.8 units on a scale
Standard Deviation 0.4
|
3.7 units on a scale
Standard Deviation 0.5
|
3.7 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline and 1 weekCorneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Corneal Coverage
1 week - No
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Corneal Coverage
Habitual toric lens - Yes
|
29 participants
|
29 participants
|
—
|
—
|
—
|
|
Corneal Coverage
Habitual toric lens - No
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Corneal Coverage
Baseline - Yes
|
29 participants
|
29 participants
|
—
|
—
|
—
|
|
Corneal Coverage
Baseline - No
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Corneal Coverage
1 week - Yes
|
29 participants
|
29 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekLens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Lens Orientation in Primary Position of Gaze
0 degrees
|
62 percentage of participants
|
72 percentage of participants
|
76 percentage of participants
|
79 percentage of participants
|
79 percentage of participants
|
|
Lens Orientation in Primary Position of Gaze
<=5 degrees
|
35 percentage of participants
|
21 percentage of participants
|
21 percentage of participants
|
7 percentage of participants
|
14 percentage of participants
|
|
Lens Orientation in Primary Position of Gaze
<=10 degrees
|
3 percentage of participants
|
7 percentage of participants
|
3 percentage of participants
|
14 percentage of participants
|
7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and 1 weekRotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=29 Participants
Habitual data was assessed at baseline.
|
Filcon IV1 Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (Baseline)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
Filcon IV1 Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
|
Ocufilcon D Toric Lens (1 Week)
n=29 Participants
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens
|
|---|---|---|---|---|---|
|
Rotational Recovery in Degrees After 60 Seconds
|
4.1 degrees
Standard Deviation 6.7
|
5.0 degrees
Standard Deviation 7.1
|
3.3 degrees
Standard Deviation 4.7
|
2.2 degrees
Standard Deviation 4.1
|
3.8 degrees
Standard Deviation 8.5
|
Adverse Events
Filcon IV1 Toric Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ocufilcon D Toric Lens
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