Astigmatism, Hyperopia, Myopia
Conditions
Brief summary
The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.
Detailed description
This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.
Interventions
DEVICEInvigor A (test)
silicone hydrogel lens
DEVICEInvigor B (control)
silicone hydrogel lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The subject will know the name of the lens however they will not be aware of which lens is investigational and which lens has been previously cleared. The licensed investigator has not been informed which lens is the investigational lens.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: 1. Be at least 18 years of age as of the date of evaluation for the study 2. Have 1. Read the informed consent document 2. Been given an explanation of the informed consent document 3. indicated understanding of the informed consent document 4. Signed the informed consent document 3. Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments. 4. Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study. 5. Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. 6. Be in good general health, based on his/her knowledge. *
Exclusion criteria
1. Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. 2. Poor personal hygiene. 3. Any active participation in another clinical trial during this trial or within 30 days prior to this study. 4. To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months. 5. A member, relative or household member of the investigator(s) or of the investigational office staff. 6. A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system. 7. Had previous refractive surgery; or current or previous orthokeratology treatment. 8. Aphakic or pseudophakic. 9. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes. 10. The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day. 11. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections. 12. A history of papillary conjunctivitis that has interfered with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Epithelial Edema - Slit Lamp Findings | Baseline | 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) |
| Number of Eyes With Stromal Edema - Slit Lamp Findings | Baseline | 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 |
| Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Baseline | 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 |
| Number of Eyes With Corneal Staining - Slit Lamp Findings | Baseline | Corneal Staining with fluorescent on slit lamp findings - Present / Absent |
| Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Baseline | Corneal Infiltrates on slit lamp findings - Present / Absent |
| Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Baseline | 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). |
| Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Baseline | 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) |
| Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Baseline | Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent |
| Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | One Month | Palpebral Conjunctival Observations on slit lamp findings - Present / Absent |
| Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | One Month | Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Invigor A (Test) 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 | 58 |
| Invigor B (Control) 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 | 30 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Invigor A (Test) | Invigor B (Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 30 Participants | 88 Participants |
| Age, Continuous | 33.19 years STANDARD_DEVIATION 8.08 | 33.73 years STANDARD_DEVIATION 8.497 | 33.38 years STANDARD_DEVIATION 8.179 |
| Race/Ethnicity, Customized Black | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Chinese | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Chinese/Japanese | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Japanese | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Japanese/Other | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 43 participants | 23 participants | 66 participants |
| Region of Enrollment United States | 58 participants | 30 participants | 88 participants |
| Sex: Female, Male Female | 39 Participants | 17 Participants | 56 Participants |
| Sex: Female, Male Male | 19 Participants | 13 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 28 |
| other Total, other adverse events | 0 / 56 | 0 / 28 |
| serious Total, serious adverse events | 0 / 56 | 0 / 28 |
Outcome results
Primary
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 1 | 24 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 0 | 88 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 0 | 50 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 1 | 6 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
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)
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 1 | 20 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 0 | 90 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 0 | 46 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 1 | 8 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Present | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Absent | 110 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Present | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Absent | 54 Eyes |
Primary
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Corneal Infiltrates on slit lamp findings - Present / Absent
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Present | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Absent | 112 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Present | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Absent | 56 Eyes |
Primary
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Present | 10 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Absent | 102 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Present | 7 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Absent | 49 Eyes |
Primary
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Present | 20 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Absent | 90 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Present | 9 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Staining - Slit Lamp Findings | Absent | 45 Eyes |
Primary
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 1 | 14 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 0 | 98 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 0 | 56 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
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
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 1 | 12 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 0 | 98 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 0 | 54 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Epithelial Edema - Slit Lamp Findings
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)
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 0 | 110 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 0 | 54 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Epithelial Edema - Slit Lamp Findings
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 0 | 112 Eyes |
| Invigor A (Test) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 0 | 56 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Epithelial Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
Primary
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
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).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 0 | 112 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 0 | 54 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 1 | 2 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
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).
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 0 | 110 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 0 | 52 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 1 | 2 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor B (Control) | 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 |
| Invigor B (Control) | Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Grade 0 | 56 Eyes |
| Invigor B (Control) | 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 |
| Invigor B (Control) | 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 |
| Invigor B (Control) | 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 |
Primary
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
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)
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor A (Test) | 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 |
| Invigor B (Control) | 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 |
| Invigor B (Control) | Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Grade 0 | 52 Eyes |
| Invigor B (Control) | Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Garde 1 | 2 Eyes |
| Invigor B (Control) | 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 |
| Invigor B (Control) | 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 |
Primary
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Present | 36 Eyes |
| Invigor A (Test) | Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Absent | 76 Eyes |
| Invigor B (Control) | Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Present | 20 Eyes |
| Invigor B (Control) | Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Absent | 36 Eyes |
Primary
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Present | 42 Eyes |
| Invigor A (Test) | Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Absent | 68 Eyes |
| Invigor B (Control) | Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Present | 12 Eyes |
| Invigor B (Control) | Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Absent | 42 Eyes |
Primary
Number of Eyes With Stromal Edema - Slit Lamp Findings
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
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 0 | 110 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 0 | 54 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
Primary
Number of Eyes With Stromal Edema - Slit Lamp Findings
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor A (Test) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 0 | 112 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 4 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 0 | 56 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 1 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 2 | 0 Eyes |
| Invigor B (Control) | Number of Eyes With Stromal Edema - Slit Lamp Findings | Grade 3 | 0 Eyes |
Secondary
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Time frame: One Month
Population: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Invigor A (Test) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/20 | 92 Eyes |
| Invigor A (Test) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/15 | 7 Eyes |
| Invigor A (Test) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/25 | 11 Eyes |
| Invigor B (Control) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/20 | 45 Eyes |
| Invigor B (Control) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/15 | 4 Eyes |
| Invigor B (Control) | Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | 20/25 | 5 Eyes |