Trial Outcomes & Findings for Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses (NCT NCT02142361)
NCT ID: NCT02142361
Last Updated: 2020-07-28
Results Overview
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
COMPLETED
NA
60 participants
Baseline and 1 week
2020-07-28
Participant Flow
Participant milestones
| Measure |
Omafilcon A/Enfilcon A
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D/Enfilcon A
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B/Enfilcon A
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Study Group
n=60 Participants
All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
|
|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Lens Initial Comfort
Habitual lens-Baseline
|
6.9 units on a scale
Standard Deviation 1.4
|
7.4 units on a scale
Standard Deviation 1.3
|
8.0 units on a scale
Standard Deviation 1.1
|
|
Participant's Subjective Rating for Lens Initial Comfort
Study lens-1 Week
|
8.9 units on a scale
Standard Deviation 1.3
|
7.8 units on a scale
Standard Deviation 1.8
|
8.1 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Lens Comfort Prior to Removal
Habitual lens -Baseline
|
7.4 units on a scale
Standard Deviation 1.2
|
7.4 units on a scale
Standard Deviation 1.7
|
6.7 units on a scale
Standard Deviation 2.0
|
|
Participant's Subjective Rating for Lens Comfort Prior to Removal
Study Lens -1 week
|
8.2 units on a scale
Standard Deviation 1.4
|
8.0 units on a scale
Standard Deviation 1.4
|
7.3 units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Lens Comfort
Habitual lens- Baseline
|
8.2 units on a scale
Standard Deviation 1.1
|
8.4 units on a scale
Standard Deviation 1.0
|
8.2 units on a scale
Standard Deviation 1.2
|
|
Participant's Subjective Rating for Overall Lens Comfort
Study lens-1 week
|
8.8 units on a scale
Standard Deviation 1.1
|
8.4 units on a scale
Standard Deviation 1.2
|
8.4 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Dryness During the Day
Habitual lens-Baseline
|
7.7 units on a scale
Standard Deviation 1.5
|
8.0 units on a scale
Standard Deviation 0.9
|
7.4 units on a scale
Standard Deviation 1.7
|
|
Participant's Subjective Rating for Dryness During the Day
Study lens-1 week
|
8.6 units on a scale
Standard Deviation 1.5
|
8.1 units on a scale
Standard Deviation 1.6
|
8.2 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Dryness Prior to Removal
Habitual lens-Baseline
|
7.4 units on a scale
Standard Deviation 1.4
|
7.0 units on a scale
Standard Deviation 1.3
|
6.3 units on a scale
Standard Deviation 2.2
|
|
Participant's Subjective Rating for Dryness Prior to Removal
Study lens-1 week
|
7.7 units on a scale
Standard Deviation 1.7
|
7.5 units on a scale
Standard Deviation 1.9
|
7.5 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Dryness
Habitual lens-Baseline
|
7.8 units on a scale
Standard Deviation 1.3
|
7.6 units on a scale
Standard Deviation 1.0
|
7.2 units on a scale
Standard Deviation 1.9
|
|
Participant's Subjective Rating for Overall Dryness
Study lens-1 week
|
8.8 units on a scale
Standard Deviation 1.2
|
8.3 units on a scale
Standard Deviation 1.4
|
8.2 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Lens Handling - Insertion
Habitual lens-Baseline
|
8.4 units on a scale
Standard Deviation 1.2
|
8.8 units on a scale
Standard Deviation 1.4
|
9.1 units on a scale
Standard Deviation 0.8
|
|
Participant's Subjective Rating for Lens Handling - Insertion
Study lens-1 week
|
9.3 units on a scale
Standard Deviation 0.7
|
8.8 units on a scale
Standard Deviation 1.0
|
9.5 units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Lens Fit Stability
Habitual lens-Baseline
|
8.1 units on a scale
Standard Deviation 1.3
|
7.8 units on a scale
Standard Deviation 1.5
|
7.9 units on a scale
Standard Deviation 1.7
|
|
Participant's Subjective Rating for Overall Lens Fit Stability
Study Lens- 1 week
|
8.1 units on a scale
Standard Deviation 1.8
|
8.0 units on a scale
Standard Deviation 1.5
|
9.0 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Vision Satisfaction
Habitual lens- Baseline
|
8.3 units on a scale
Standard Deviation 1.1
|
8.1 units on a scale
Standard Deviation 1.6
|
8.6 units on a scale
Standard Deviation 1.4
|
|
Participant's Subjective Rating for Overall Vision Satisfaction
Study lens-1 week
|
8.6 units on a scale
Standard Deviation 1.1
|
8.7 units on a scale
Standard Deviation 1.0
|
9.3 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Quality at Insertion
Habitual lens-Baseline
|
77 units on a scale
Standard Deviation 10.3
|
75.5 units on a scale
Standard Deviation 11.9
|
79.5 units on a scale
Standard Deviation 10.0
|
|
Participant's Subjective Rating for Vision Quality at Insertion
Study lens-1 week
|
87.5 units on a scale
Standard Deviation 12.1
|
82.5 units on a scale
Standard Deviation 12.5
|
86.5 units on a scale
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Quality During the Day
Habitual lens-Baseline
|
83 units on a scale
Standard Deviation 11.3
|
86 units on a scale
Standard Deviation 11.0
|
84.5 units on a scale
Standard Deviation 11.9
|
|
Participant's Subjective Rating for Vision Quality During the Day
Study lens-1 week
|
87.5 units on a scale
Standard Deviation 11.2
|
85 units on a scale
Standard Deviation 8.9
|
91.5 units on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Quality End of the Day
Habitual lens-Baseline
|
79 units on a scale
Standard Deviation 10.2
|
82.5 units on a scale
Standard Deviation 14.1
|
76 units on a scale
Standard Deviation 14.1
|
|
Participant's Subjective Rating for Vision Quality End of the Day
Study lens-1 week
|
79.8 units on a scale
Standard Deviation 17.2
|
80.5 units on a scale
Standard Deviation 13.9
|
87.5 units on a scale
Standard Deviation 9.7
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Night Vision Quality
Habitual lens-Baseline
|
77.3 units on a scale
Standard Deviation 7.2
|
83.3 units on a scale
Standard Deviation 10.5
|
81.8 units on a scale
Standard Deviation 10.0
|
|
Participant's Subjective Rating for Night Vision Quality
Study lens-1 week
|
83.5 units on a scale
Standard Deviation 8.6
|
84.5 units on a scale
Standard Deviation 7.8
|
87.3 units on a scale
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Stability at Insertion
Habitual lenses-Baseline
|
74 units on a scale
Standard Deviation 10.5
|
70 units on a scale
Standard Deviation 12.6
|
71.5 units on a scale
Standard Deviation 15.3
|
|
Participant's Subjective Rating for Vision Stability at Insertion
Study lens-1 week
|
86.5 units on a scale
Standard Deviation 11.4
|
81 units on a scale
Standard Deviation 14.1
|
85.5 units on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Stability During the Day
Habitual lens-Baseline
|
83 units on a scale
Standard Deviation 8.6
|
81.5 units on a scale
Standard Deviation 10.9
|
77.5 units on a scale
Standard Deviation 16.2
|
|
Participant's Subjective Rating for Vision Stability During the Day
Study lens-1 week
|
82.5 units on a scale
Standard Deviation 11.6
|
82.5 units on a scale
Standard Deviation 12.1
|
90 units on a scale
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: Baseline and 1 weekSurveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Outcome measures
| Measure |
Omafilcon A
n=20 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=20 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
n=20 Participants
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Vision Stability at End of Day
Habitual lens-Baseline
|
81 units on a scale
Standard Deviation 9.1
|
79.5 units on a scale
Standard Deviation 13.9
|
75.5 units on a scale
Standard Deviation 16.4
|
|
Participant's Subjective Rating for Vision Stability at End of Day
Study lens-1 week
|
77.5 units on a scale
Standard Deviation 16.8
|
82 units on a scale
Standard Deviation 13.2
|
88.5 units on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: 1 weekPopulation: All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. "Vision" category data for one participant was not collected.
Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.
Outcome measures
| Measure |
Omafilcon A
n=120 eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Lens Pair Preference
Overall
|
10 Percentage of eyes
|
90 Percentage of eyes
|
—
|
|
Participant's Subjective Rating for Lens Pair Preference
Comfort
|
13 Percentage of eyes
|
87 Percentage of eyes
|
—
|
|
Participant's Subjective Rating for Lens Pair Preference
Dryness
|
25 Percentage of eyes
|
75 Percentage of eyes
|
—
|
|
Participant's Subjective Rating for Lens Pair Preference
Handling
|
17 Percentage of eyes
|
83 Percentage of eyes
|
—
|
|
Participant's Subjective Rating for Lens Pair Preference
Vision
|
13 Percentage of eyes
|
85 Percentage of eyes
|
—
|
|
Participant's Subjective Rating for Lens Pair Preference
Lens Fit
|
10 Percentage of eyes
|
90 Percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Dryness
completely satisfied
|
27 percentage of eyes
|
40 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Dryness
somewhat satisfied
|
55 percentage of eyes
|
42 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Dryness
somewhat dissatisfied
|
18 percentage of eyes
|
13 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Dryness
completely dissatisfied
|
0 percentage of eyes
|
5 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. Sum of percentage for the Study Lens Arm=101 as, Category title- " Somewhat dissatisfied- 1.7 was rounded to 2.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Handling
completely satisfied
|
73 percentage of eyes
|
87 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Handling
somewhat satisfied
|
23 percentage of eyes
|
12 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Handling
somewhat dissatisfied
|
3 percentage of eyes
|
2 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Handling
completely dissatisfied
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Vision
completely satisfied
|
48 percentage of eyes
|
62 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Vision
somewhat satisfied
|
43 percentage of eyes
|
37 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Vision
somewhat dissatisfied
|
8 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Vision
completely dissatisfied
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
completely satisfied
|
40 percentage of eyes
|
65 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
somewhat satisfied
|
42 percentage of eyes
|
23 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
somewhat dissatisfied
|
18 percentage of eyes
|
12 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Lens Fit
completely dissatisfied
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Overall
completely satisfied
|
30 percentage of eyes
|
58 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Overall
somewhat satisfied
|
67 percentage of eyes
|
42 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Overall
somewhat dissatisfied
|
3 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Overall
completely dissatisfied
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.
Outcome measures
| Measure |
Omafilcon A
n=60 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Objective Assessment Monocular High Contrast Distance Visual
VA Oculus Dexter (OD)
|
-0.037 LogMAR
Standard Deviation 0.049
|
-0.037 LogMAR
Standard Deviation 0.049
|
—
|
|
Clinician's Objective Assessment Monocular High Contrast Distance Visual
VA Oculus Sinister (OS)
|
-0.037 LogMAR
Standard Deviation 0.049
|
-0.037 LogMAR
Standard Deviation 0.049
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value
Outcome measures
| Measure |
Omafilcon A
n=60 Participants
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Participants
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity
|
-0.037 LogMAR
Standard Deviation 0.0049
|
-0.037 LogMAR
Standard Deviation 0.0049
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Overall Lens Stability-Right Eye
Very Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Right Eye
Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Right Eye
Moderate
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Right Eye
Good
|
62 percentage of eyes
|
8 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Right Eye
Excellent
|
38 percentage of eyes
|
92 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Overall Lens Stability-Left Eye
Very Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Left Eye
Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Left Eye
Moderate
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Left Eye
Good
|
55 percentage of eyes
|
5 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Lens Stability-Left Eye
Excellent
|
45 percentage of eyes
|
95 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Overall Fit Acceptance- Right Eye
Very Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Right Eye
Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Right Eye
Moderate
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Right Eye
Good
|
48 percentage of eyes
|
3 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Right Eye
Excellent
|
52 percentage of eyes
|
97 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Overall Fit Acceptance- Left Eye
Very Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Left Eye
Poor
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Left Eye
Moderate
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Left Eye
Good
|
48 percentage of eyes
|
3 percentage of eyes
|
—
|
|
Clinician's Assessment Overall Fit Acceptance- Left Eye
Excellent
|
52 percentage of eyes
|
97 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (\>0.5mm))
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Lens Centration-Right Eye
Centered
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Centration-Right Eye
Slightly decentered
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Centration-Right Eye
Substantially decentered
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (\>0.5mm)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Lens Centration- Left Eye
Centered
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Centration- Left Eye
Slightly decentered
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Centration- Left Eye
Substantially decentered
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Corneal Coverage-Right Eye
Full corneal coverage
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Corneal Coverage-Right Eye
Incomplete corneal coverage
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinicians Assessment Corneal Coverage-Left Eye
Full corneal coverage
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinicians Assessment Corneal Coverage-Left Eye
Incomplete corneal coverage
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Post-Blink Movement- Right Eye
Insufficient/Unacceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement- Right Eye
Minimal, but acceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement- Right Eye
Optimal movement,
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement- Right Eye
Moderate, but acceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement- Right Eye
Excessive, inacceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Post-Blink Movement-Left Eye
Insufficient/Unacceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement-Left Eye
Minimal, but acceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement-Left Eye
Optimal movement
|
100 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement-Left Eye
Moderate, but acceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Post-Blink Movement-Left Eye
Excessive,unacceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
Temporal
|
12 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
0 rotation
|
18 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
Nasal
|
70 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
Temporal
|
12 percentage of eyes
|
0 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
0 rotation
|
73 percentage of eyes
|
100 percentage of eyes
|
—
|
|
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
Nasal
|
15 percentage of eyes
|
0 percentage of eyes
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye
|
0 degrees
Standard Deviation 0
|
0 degrees
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Outcome measures
| Measure |
Omafilcon A
n=60 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=60 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye
|
0 degrees
Standard Deviation 0
|
0 degrees
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.
Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Outcome measures
| Measure |
Omafilcon A
n=120 Eyes
Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Ocufilcon D
n=120 Eyes
Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
Methafilcon B
Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
|
|---|---|---|---|
|
Participant's Subjective Rating for Overall Satisfaction - Comfort
Completely satisfied
|
30 percentage of eyes
|
55 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Comfort
somewhat satisfied
|
58 percentage of eyes
|
40 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Comfort
somewhat dissatisfied
|
12 percentage of eyes
|
5 percentage of eyes
|
—
|
|
Participant's Subjective Rating for Overall Satisfaction - Comfort
completely dissatisfied
|
0 percentage of eyes
|
0 percentage of eyes
|
—
|
Adverse Events
Omafilcon A
Ocufilcon D
Methafilcon B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Montés-Mico O.D., MPhil, PhD Optometry
Optometry Research Group (GIO)
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER