Trial Outcomes & Findings for Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses (NCT NCT01966770)
NCT ID: NCT01966770
Last Updated: 2020-07-30
Results Overview
Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2020-07-30
Participant Flow
Participant milestones
| Measure |
Overall Study Group
All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Study Group
n=20 Participants
All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
10 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselineAssessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Visual Acuity (VA) logMAR (Habitual Lenses)
|
-0.06 LogMar
Standard Deviation 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: DispenseAssessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Visual Acuity (VA) logMAR (Study Lenses)
|
-0.13 LogMAR
Standard Deviation 0.06
|
-0.11 LogMAR
Standard Deviation 0.07
|
-0.13 LogMAR
Standard Deviation 0.06
|
-0.12 LogMAR
Standard Deviation 0.06
|
-0.13 LogMAR
Standard Deviation 0.07
|
-0.11 LogMAR
Standard Deviation 0.08
|
-0.13 LogMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Day 1 - InsertionParticipant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Contact Lens Insertion (Day 1 Study Lenses)
|
92 units on a scale
Standard Deviation 8
|
95 units on a scale
Standard Deviation 6
|
95 units on a scale
Standard Deviation 7
|
97 units on a scale
Standard Deviation 5
|
95 units on a scale
Standard Deviation 8
|
96 units on a scale
Standard Deviation 6
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesParticipant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)
|
97 units on a scale
Standard Deviation 1.8
|
96 units on a scale
Standard Deviation 1.3
|
96 units on a scale
Standard Deviation 1.6
|
96 units on a scale
Standard Deviation 1.1
|
96 units on a scale
Standard Deviation 1.8
|
95 units on a scale
Standard Deviation 1.3
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionParticipant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Contact Lens Insertion (Day 2 Study Lenses)
|
94 units on a scale
Standard Deviation 14
|
92 units on a scale
Standard Deviation 16
|
93 units on a scale
Standard Deviation 14
|
96 units on a scale
Standard Deviation 8.0
|
94 units on a scale
Standard Deviation 10
|
97 units on a scale
Standard Deviation 9.0
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesParticipant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
|
96 units on a scale
Standard Deviation 6.0
|
93 units on a scale
Standard Deviation 13
|
94 units on a scale
Standard Deviation 10
|
96 units on a scale
Standard Deviation 6.0
|
97 units on a scale
Standard Deviation 7.0
|
98 units on a scale
Standard Deviation 3.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 - InsertionParticipant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
B55 PREMIER ASPHERE LENS P1
|
35 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
B55 SPHERE LENS P1
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
No Preference
|
60 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 InsertionParticipant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
No Preference
|
85 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
B55 SPHERE LENS P2
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
AV SPHERE LENS P2
|
15 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - InsertionParticipant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
B55 SPHERE LENS P3
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
20 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
No Preference
|
70 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
B55 SPHERE LENS P1
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
B55 PREMIER ASPHERE LENS P1
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
No Preference
|
85 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
AV SPHERE LENS P2
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
No Preference
|
90 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
B55 SPHERE LENS P2
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
B55 SPHERE LENS P3
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
No Preference
|
85 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionParticipant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
F55 SPHERE LENS P1
|
20 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
F55 PREMIER ASPHERE LENS P1
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
No Preference
|
70 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionParticipant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
F55 SPHERE LENS P2
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
BIOFINITY LENS P2
|
15 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
No Preference
|
75 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionParticipant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
PCM SPHERE LENS P3
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
15 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
No Preference
|
80 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
F55 SPHERE LENS P1
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
F55 PREMIER ASPHERE LENS P1
|
15 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
No Preference
|
75 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
F55 SPHERE LENS P2
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
BIOFINITY LENS P2
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
No Preference
|
80 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesParticipant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
PCM SPHERE LENS P3
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
20 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
No Preference
|
80 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineAssessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Outcome measures
| Measure |
Habitual Lens
n=40 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Centration (Habitual Lens)
|
75 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineAssessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Outcome measures
| Measure |
Habitual Lens
n=40 eyes
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Tightness (Habitual Lens)
|
46 percentage
Standard Deviation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineAssessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)
Outcome measures
| Measure |
Habitual Lens
n=40 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
Upgaze Lag
|
0.21 millimeters
Standard Deviation 0.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
Post-blink Movement
|
0.19 millimeters
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesAssessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Outcome measures
| Measure |
Habitual Lens
n=20 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Centration (Day 1 Study Lenses)
|
100 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
90 percentage of lenses
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesAssessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Outcome measures
| Measure |
Habitual Lens
n=20 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)
|
50 percentage
Standard Deviation 13
|
48 percentage
Standard Deviation 13
|
51 percentage
Standard Deviation 13
|
45 percentage
Standard Deviation 11
|
52 percentage
Standard Deviation 16
|
54 percentage
Standard Deviation 11
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesAssessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)
Outcome measures
| Measure |
Habitual Lens
n=40 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=40 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=40 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=40 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=40 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=40 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
Upper Gaze Lag
|
0.00 millimeter
Standard Deviation 0.00
|
0.00 millimeter
Standard Deviation 0.00
|
0.00 millimeter
Standard Deviation 0.00
|
0.05 millimeter
Standard Deviation 0.22
|
0.00 millimeter
Standard Deviation 0.00
|
0.00 millimeter
Standard Deviation 0.00
|
—
|
|
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
Post-blink Movement
|
0.39 millimeter
Standard Deviation 0.43
|
0.39 millimeter
Standard Deviation 0.40
|
0.28 millimeter
Standard Deviation 0.29
|
0.41 millimeter
Standard Deviation 0.28
|
0.27 millimeter
Standard Deviation 0.27
|
0.30 millimeter
Standard Deviation 0.25
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesAssessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Outcome measures
| Measure |
Habitual Lens
n=20 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
|
95 percentage of lenses
|
95 percentage of lenses
|
95 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesAssessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Outcome measures
| Measure |
Habitual Lens
n=20 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
|
53 percentage
Standard Deviation 13.4
|
50 percentage
Standard Deviation 14.9
|
51 percentage
Standard Deviation 13.5
|
53 percentage
Standard Deviation 12.3
|
53 percentage
Standard Deviation 15.2
|
55 percentage
Standard Deviation 11.7
|
—
|
PRIMARY outcome
Timeframe: Day 2 - 30 minutesAssessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)
Outcome measures
| Measure |
Habitual Lens
n=20 lens
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 lens
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
Post-blink Movement
|
0.32 millimeters
Standard Deviation 0.25
|
0.33 millimeters
Standard Deviation 0.22
|
0.31 millimeters
Standard Deviation 0.35
|
0.23 millimeters
Standard Deviation 0.21
|
0.39 millimeters
Standard Deviation 0.42
|
0.25 millimeters
Standard Deviation 0.20
|
—
|
|
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
Upper Gaze Lag
|
0.11 millimeters
Standard Deviation 0.45
|
0.14 millimeters
Standard Deviation 0.45
|
0.13 millimeters
Standard Deviation 0.38
|
0.05 millimeters
Standard Deviation 0.16
|
0.33 millimeters
Standard Deviation 0.73
|
0.00 millimeters
Standard Deviation 0.00
|
—
|
PRIMARY outcome
Timeframe: Day 1- 30 minutesInvestigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=40 eyes
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
B55 SPHERE LENS P1
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
B55 PREMIER ASPHERE LENS P1
|
10 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
No Preference
|
85 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1- 30 minutesInvestigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=40 eyes
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
B55 SPHERE LENS P2
|
15 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
AV SPHERE LENS P2
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
No Preference
|
80 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - 30 minutesInvestigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=40 eyes
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
B55 SPHERE LENS P3
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
10 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
No Preference
|
85 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionInvestigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
F55 SPHERE LENS P1
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
F55 PREMIER ASPHERE LENS P1
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
No Preference
|
90 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionInvestigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
F55 SPHERE LENS P2
|
10 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
BIOFINITY LENS P2
|
40 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
No Preference
|
50 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 - InsertionInvestigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
PCM SPHERE LENS P3
|
5 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
BF SPHERE LENS P3
|
35 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
No Preference
|
60 percentage of investigators
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 - After RemovalParticipant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Overall Ease of Lens Handling (Day 1 Study Lenses)
|
95 units on a scale
Standard Deviation 10
|
95 units on a scale
Standard Deviation 10
|
95 units on a scale
Standard Deviation 10
|
93 units on a scale
Standard Deviation 12
|
94 units on a scale
Standard Deviation 9.3
|
92 units on a scale
Standard Deviation 15.4
|
—
|
PRIMARY outcome
Timeframe: Day 2 - After RemovalParticipant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy
Outcome measures
| Measure |
Habitual Lens
n=20 Participants
Subjects presented wearing habitual lenses prior to dispense of study lenses.
|
B55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
|
BF SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
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AV SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
|
PCM SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
|
F55 SPHERE LENS
n=20 Participants
Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
|
F55 ASPHERE LENS
Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
|
|---|---|---|---|---|---|---|---|
|
Overall Ease of Lens Handling (Day 2 Study Lenses)
|
96 units on a scale
Standard Deviation 7.6
|
96 units on a scale
Standard Deviation 8.1
|
96 units on a scale
Standard Deviation 9.8
|
94 units on a scale
Standard Deviation 12
|
94 units on a scale
Standard Deviation 16
|
94 units on a scale
Standard Deviation 16
|
—
|
Adverse Events
Pair 1 (Ocufilcon D / Ocufilcon D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pair 2 (Ocufilcon D / Enfilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pair 3 (Ocufilcon D / Comfilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pair 4 (Methafilcon A / Methafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pair 5 (Methafilcon A / Comfilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pair 6 (Omafilcon A / Comfilcon A)
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
Meng C. Lin O.D., PhD, FAAO
Clinical Research Center-UC berkely
Phone: 510-643-9252
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER