Trial Outcomes & Findings for Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear (NCT NCT03722784)
NCT ID: NCT03722784
Last Updated: 2020-10-01
Results Overview
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - \>100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
COMPLETED
NA
88 participants
Baseline
2020-10-01
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Invigor A (Test)
Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Overall Study
STARTED
|
58 116
|
30 60
|
|
Overall Study
COMPLETED
|
56 112
|
28 56
|
|
Overall Study
NOT COMPLETED
|
2 4
|
2 4
|
Reasons for withdrawal
| Measure |
Invigor A (Test)
Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
Baseline characteristics by cohort
| Measure |
Invigor A (Test)
n=58 Participants
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=30 Participants
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study.
Invigor B (Control): silicone hydrogel lens
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
88 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
33.19 years
STANDARD_DEVIATION 8.080 • n=39 Participants
|
33.73 years
STANDARD_DEVIATION 8.497 • n=41 Participants
|
33.38 years
STANDARD_DEVIATION 8.179 • n=35 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 participants
n=39 Participants
|
0 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
5 participants
n=39 Participants
|
3 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
43 participants
n=39 Participants
|
23 participants
n=41 Participants
|
66 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=39 Participants
|
2 participants
n=41 Participants
|
2 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Chinese/Japanese
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Japanese/Other
|
2 participants
n=39 Participants
|
0 participants
n=41 Participants
|
2 participants
n=35 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=39 Participants
|
30 participants
n=41 Participants
|
88 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: BaselineEpithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - \>100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 0
|
112 Eyes
|
56 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - \>100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 0
|
110 Eyes
|
54 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselineStromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 0
|
112 Eyes
|
56 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 0
|
110 Eyes
|
54 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Stromal Edema - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselineCorneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: \<1.00 mm vessel penetration, 2 Mild: \>1.00 mm to \<1.50 mm vessel penetration, 3 Moderate: \>1.50 mm to \<2.00 mm vessel penetration, 4 Severe: Vessel penetration \>2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 0
|
98 Eyes
|
56 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 1
|
14 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: \<1.00 mm vessel penetration, 2 Mild: \>1.00 mm to \<1.50 mm vessel penetration, 3 Moderate: \>1.50 mm to \<2.00 mm vessel penetration, 4 Severe: Vessel penetration \>2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 0
|
98 Eyes
|
54 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 1
|
12 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselineCorneal Staining with fluorescent on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Staining - Slit Lamp Findings
Present
|
10 Eyes
|
7 Eyes
|
|
Number of Eyes With Corneal Staining - Slit Lamp Findings
Absent
|
102 Eyes
|
49 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Staining - Slit Lamp Findings
Present
|
20 Eyes
|
9 Eyes
|
|
Number of Eyes With Corneal Staining - Slit Lamp Findings
Absent
|
90 Eyes
|
45 Eyes
|
PRIMARY outcome
Timeframe: BaselineCorneal Infiltrates on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Present
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Absent
|
112 Eyes
|
56 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Present
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Absent
|
110 Eyes
|
54 Eyes
|
PRIMARY outcome
Timeframe: BaselineLimbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 0
|
112 Eyes
|
54 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 1
|
0 Eyes
|
2 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 0
|
110 Eyes
|
52 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 1
|
0 Eyes
|
2 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselineBulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 0
|
88 Eyes
|
50 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 1
|
24 Eyes
|
6 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 0
|
90 Eyes
|
46 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 1
|
20 Eyes
|
8 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: BaselineNumber of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Present
|
36 Eyes
|
20 Eyes
|
|
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Absent
|
76 Eyes
|
36 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Present
|
42 Eyes
|
12 Eyes
|
|
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Absent
|
68 Eyes
|
42 Eyes
|
PRIMARY outcome
Timeframe: BaselineClinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Outcome measures
| Measure |
Invigor A (Test)
n=112 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=56 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 0
|
112 Eyes
|
56 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Garde 1
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 0
|
106 Eyes
|
52 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Garde 1
|
4 Eyes
|
2 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: One MonthPopulation: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Outcome measures
| Measure |
Invigor A (Test)
n=110 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) for one month of daily wear during the study.
Invigor A (test): silicone hydrogel lens
|
Invigor B (Control)
n=54 Eyes
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study.
Invigor B (control): silicone hydrogel lens
|
|---|---|---|
|
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
20/20
|
92 Eyes
|
45 Eyes
|
|
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
20/15
|
7 Eyes
|
4 Eyes
|
|
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
20/25
|
11 Eyes
|
5 Eyes
|
Adverse Events
Invigor A (Test)
Invigor B (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place