Ametropia
Conditions
Brief summary
The purpose of the study is to compare the investigational contact lens to a marketed contact lens. The study results were not used for design validation of investigational contact lens,
Detailed description
The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality. The study results were not used for design validation of investigational contact lens,
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior to being considered eligible to participate in this study, each subject MUST: 1. Be at least 18 years of age as of the date of evaluation for the study. 2. Have: 1. Read the Informed Consent 2. been given an explanation of the Informed Consent 3. indicated understanding of the Informed Consent 4. signed the Informed Consent document. 3. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. 4. Be an adapted, 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. 7. Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes. 8. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye. 9. To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.
Exclusion criteria
* Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has: 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 or of the investigational office staff. 6. Has a known sensitivity to the ingredients used in the MPS approved for use in the study and is unable or unwilling to use the alternate care system. 7. Previous refractive surgery; or current or previous orthokeratology treatment. 8. Is aphakic or psuedophakic. 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. The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures. 12. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections. 13. A history of papillary conjunctivitis that has interfered with contact lens wear. 14. Slit lamp findings that would contraindicate contact lens wear, including but not limited to: * Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> Grade 2 * Pterygium * Corneal scars within the visual axis * Neovascularization or ghost vessels \> 1.0 mm in from the limbus * Giant papillary conjunctivitis (GPC) of \> Grade 2 * Anterior uveitis or iritis * Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings for Epithelial Edema | 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) |
| Slit Lamp Findings for Stromal Edema | 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) |
| Slit Lamp Findings for Corneal Infiltrates | Baseline (After lens dispensing) | Slit Lamp Findings for Corneal Infiltrates - Present, Absent |
| Slit Lamp Findings for Corneal Vascularization | 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) |
| Slit Lamp Findings for Limbal Hyperemia | 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) |
| Slit Lamp Findings for Bulbar Hyperemia | 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) |
| Slit Lamp Findings for Palpebral Conjunctiva | Baseline (After lens dispensing) | Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent |
| Slit Lamp Findings for Other Findings | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 59 |
| 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 | 30 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Sapphire | Pearl | 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 | 59 Participants | 30 Participants | 89 Participants |
| Age, Continuous | 32.8 years STANDARD_DEVIATION 8.82 | 33.3 years STANDARD_DEVIATION 8.89 | 32.9 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Japanese | 9 participants | 5 participants | 14 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 47 participants | 23 participants | 70 participants |
| Region of Enrollment United States | 59 participants | 30 participants | 89 participants |
| Sex: Female, Male Female | 40 Participants | 18 Participants | 58 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 30 |
| other Total, other adverse events | 7 / 59 | 2 / 30 |
| serious Total, serious adverse events | 0 / 59 | 0 / 30 |
Outcome results
Primary
Slit Lamp Findings for Bulbar Hyperemia
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)
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 1 | 33 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 2 | 1 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 0 | 70 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 0 | 42 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 1 | 14 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Bulbar Hyperemia
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 1 | 42 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Bulbar Hyperemia | Grade 0 | 64 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 0 | 41 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 1 | 17 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Bulbar Hyperemia | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Corneal Infiltrates | Present | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Infiltrates | Absent | 106 Eyes |
| Pearl | Slit Lamp Findings for Corneal Infiltrates | Present | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Infiltrates | Absent | 58 Eyes |
Primary
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Time frame: 1 Month
Population: Data for two test lens and two control lens were not collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Corneal Infiltrates | Present | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Infiltrates | Absent | 104 Eyes |
| Pearl | Slit Lamp Findings for Corneal Infiltrates | Present | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Infiltrates | Absent | 56 Eyes |
Primary
Slit Lamp Findings for Corneal Vascularization
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)
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 1 | 3 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 0 | 101 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 0 | 52 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 1 | 4 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Corneal Vascularization
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 1 | 3 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Corneal Vascularization | Grade 0 | 103 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 0 | 52 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 1 | 6 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Corneal Vascularization | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Epithelial Edema
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 0 | 106 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 1 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 3 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 0 | 58 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 1 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 2 | 0 Eyes |
Primary
Slit Lamp Findings for Epithelial Edema
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)
Time frame: 1 Month
Population: Data for two test eyes and two control eyes were not collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 1 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Epithelial Edema | Grade 0 | 104 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 0 | 56 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 1 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 3 | 0 Eyes |
| Pearl | Slit Lamp Findings for Epithelial Edema | Grade 2 | 0 Eyes |
Primary
Slit Lamp Findings for Limbal Hyperemia
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 0 | 77 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 1 | 29 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 3 | 0 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 0 | 48 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 1 | 10 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 4 | 0 Eyes |
Primary
Slit Lamp Findings for Limbal Hyperemia
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)
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 1 | 28 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Limbal Hyperemia | Grade 0 | 76 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 0 | 44 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 1 | 12 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Limbal Hyperemia | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Other Findings
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Other Findings | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 0 | 104 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 1 | 2 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 3 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 3 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 0 | 54 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 1 | 4 Eyes |
Primary
Slit Lamp Findings for Other Findings
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)
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Other Findings | Grade 1 | 3 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Other Findings | Grade 0 | 101 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 0 | 54 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 1 | 2 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Other Findings | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Palpebral Conjunctiva | Present | 34 Eyes |
| Sapphire | Slit Lamp Findings for Palpebral Conjunctiva | Absent | 72 Eyes |
| Pearl | Slit Lamp Findings for Palpebral Conjunctiva | Present | 19 Eyes |
| Pearl | Slit Lamp Findings for Palpebral Conjunctiva | Absent | 39 Eyes |
Primary
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Palpebral Conjunctiva | Present | 47 Eyes |
| Sapphire | Slit Lamp Findings for Palpebral Conjunctiva | Absent | 57 Eyes |
| Pearl | Slit Lamp Findings for Palpebral Conjunctiva | Present | 20 Eyes |
| Pearl | Slit Lamp Findings for Palpebral Conjunctiva | Absent | 36 Eyes |
Primary
Slit Lamp Findings for Stromal Edema
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)
Time frame: 1 month
Population: Data for two test eyes and two control eyes were not collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 1 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 0 | 104 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 0 | 56 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 1 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 3 | 0 Eyes |
Primary
Slit Lamp Findings for Stromal Edema
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)
Time frame: Baseline (After lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 1 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 3 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 2 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 4 | 0 Eyes |
| Sapphire | Slit Lamp Findings for Stromal Edema | Grade 0 | 106 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 4 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 0 | 58 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 1 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 2 | 0 Eyes |
| Pearl | Slit Lamp Findings for Stromal Edema | Grade 3 | 0 Eyes |