Investigational Contact Lens
DeviceSenofilcon C Toric
NCT Number: NCT03086447
Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate that the investigational contact lens meets the design requirements related to corneal staining, lens fit, visual acuity and rotational performance as well as subjective comfort and handling. Subjects will wear the contact lenses for a total of 28-36 days.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Golden Optometric Group, Whittier, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Senofilcon C Toric
Air Optix for Astigmatism
Time frame: Up to 4-Week Follow-up
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was "20/40 or better (acceptable VA)" or "worse than 20/40 (unacceptable VA)". VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.
Time frame: 15-minutes Post Lens Insertion
Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.
Time frame: Up to 4-Week Follow-up
Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.
Time frame: Up to 4- Week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: Up to 4- Week Follow-up
Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 15 Minutes Post Lens Fitting
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was "20/20 or better (optimal VA)" or "worse than 20/20". VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens.
Johnson & Johnson Vision Care, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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