Trial Outcomes & Findings for Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear (NCT NCT02362724)
NCT ID: NCT02362724
Last Updated: 2020-10-14
Results Overview
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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
89 participants
Baseline (After lens dispensing)
2020-10-14
Participant Flow
Participant milestones
| Measure |
Sapphire
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
30
|
|
Overall Study
COMPLETED
|
53
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Sapphire
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
Baseline Characteristics
Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear
Baseline characteristics by cohort
| Measure |
Sapphire
n=59 Participants
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=30 Participants
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 8.820 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 8.890 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 8.800 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 participants
n=5 Participants
|
23 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
30 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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 |
Sapphire
n=53 Participants
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=29 Participants
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Epithelial Edema
Grade 0
|
106 Eyes
|
58 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 MonthPopulation: Data for two test eyes and two control eyes were not collected.
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: 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 |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Epithelial Edema
Grade 0
|
104 Eyes
|
56 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Epithelial Edema
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and \>4 pronounced striae)
Outcome measures
| Measure |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=58 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Stromal Edema
Grade 0
|
106 Eyes
|
58 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected
Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and \>4 pronounced striae)
Outcome measures
| Measure |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Stromal Edema
Grade 0
|
104 Eyes
|
56 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 1
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Stromal Edema
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Outcome measures
| Measure |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=58 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Corneal Infiltrates
Present
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Infiltrates
Absent
|
106 Eyes
|
58 Eyes
|
PRIMARY outcome
Timeframe: 1 MonthPopulation: Data for two test lens and two control lens were not collected
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Outcome measures
| Measure |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Corneal Infiltrates
Present
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Infiltrates
Absent
|
104 Eyes
|
56 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Corneal Vascularization on a grade 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)
Outcome measures
| Measure |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=58 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Corneal Vascularization
Grade 0
|
103 Eyes
|
52 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 1
|
3 Eyes
|
6 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected
Slit Lamp Findings for Corneal Vascularization on a grade 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)
Outcome measures
| Measure |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Corneal Vascularization
Grade 0
|
101 Eyes
|
52 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 1
|
3 Eyes
|
4 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Corneal Vascularization
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=58 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 0
|
77 Eyes
|
48 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 1
|
29 Eyes
|
10 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected.
Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 0
|
76 Eyes
|
44 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 1
|
28 Eyes
|
12 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Limbal Hyperemia
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=29 Participants
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 0
|
64 Eyes
|
41 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 1
|
42 Eyes
|
17 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected.
Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 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 |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 0
|
70 Eyes
|
42 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 1
|
33 Eyes
|
14 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 2
|
1 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Bulbar Hyperemia
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Outcome measures
| Measure |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=58 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Palpebral Conjunctiva
Present
|
34 Eyes
|
19 Eyes
|
|
Slit Lamp Findings for Palpebral Conjunctiva
Absent
|
72 Eyes
|
39 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Outcome measures
| Measure |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Palpebral Conjunctiva
Present
|
47 Eyes
|
20 Eyes
|
|
Slit Lamp Findings for Palpebral Conjunctiva
Absent
|
57 Eyes
|
36 Eyes
|
PRIMARY outcome
Timeframe: Baseline (After lens dispensing)Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Outcome measures
| Measure |
Sapphire
n=106 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Other Findings
Grade 0
|
104 Eyes
|
54 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 1
|
2 Eyes
|
4 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data for two test eyes and two control eyes were not collected
Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Outcome measures
| Measure |
Sapphire
n=104 Eyes
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=56 Eyes
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Slit Lamp Findings for Other Findings
Grade 0
|
101 Eyes
|
54 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 1
|
3 Eyes
|
2 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 2
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Slit Lamp Findings for Other Findings
Grade 4
|
0 Eyes
|
0 Eyes
|
Adverse Events
Sapphire
Pearl
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sapphire
n=59 participants at risk
Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration
Sapphire: silicone hydrogel contact lens
|
Pearl
n=30 participants at risk
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
|
|---|---|---|
|
Eye disorders
Pappilary Conjuctivitis
|
10.2%
6/59 • Number of events 6 • From Dispense up to one month on study lenses
|
3.3%
1/30 • Number of events 1 • From Dispense up to one month on study lenses
|
|
Eye disorders
Corneal Infiltrate
|
0.00%
0/59 • From Dispense up to one month on study lenses
|
3.3%
1/30 • Number of events 1 • From Dispense up to one month on study lenses
|
|
Eye disorders
Foreign body Abrasion
|
1.7%
1/59 • Number of events 1 • From Dispense up to one month on study lenses
|
0.00%
0/30 • From Dispense up to one month on study lenses
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place