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,
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,
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
89
Eric M White OD, Inc.
San Diego, California, United States
Office of Mark E Nakano, O.D.
Torrance, California, United States
Advanced Family Eye Care
Denver, North Carolina, United States
Quinn Foster & Associates
Athens, Ohio, United States
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)
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
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)
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
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
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Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States
Premier Vision Services, LLC
Amarillo, Texas, United States
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Time frame: 1 Month
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)
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
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)
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
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)
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
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Time frame: 1 month
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)
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