The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
371
Soft contact lens to be worn as daily wear, monthly replacement modality.
Soft contact lens to be worn as daily wear, daily disposable modality.
Unnamed facility
Montgomery, Alabama, United States
Unnamed facility
Mission Viejo, California, United States
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time frame: 8 -12 days post wear
Distance Binocular Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Time frame: 8- 12 Days post wear
Intermediate Binocular Visual Acuity (LogMAR)
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Near Binocular Visual Acuity (LogMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Corneal Staining
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
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Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Orange Park, Florida, United States
Unnamed facility
Saint Augustine, Florida, United States
Unnamed facility
Tallahassee, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Winter Park, Florida, United States
Unnamed facility
Roswell, Georgia, United States
...and 10 more locations
Time frame: 8 - 12 Days post wear
Bulbar Conjunctival Injection
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Limbal Conjunctival Injection
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Contact Lens Fitting
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Time frame: 8- 12 Days post wear