Test 8.5BC
Devicesenofilcon A contact lenses with 8.5 base curve
NCT Number: NCT03139578
This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Aston University Optometry and Vision Science, Birmingham, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
senofilcon A contact lenses with 8.5 base curve
senofilcon A contact lenses with 9.0 base curve
narafilcon A contact lenses with 8.5 base curve
narafilcon A contact lenses with 9.0 base curve
Time frame: 30-45 minutes after lens settling
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
Time frame: 30-45 minutes after lens settling
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
Time frame: Immediately upon lens insertion
Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.
Time frame: Immediately upon lens insertion
Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.
Johnson & Johnson Vision Care, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07174596
Visual Acuity
Roswell, Georgia, United States
View Trial DetailsNCT07076160
Eye Diseases, Presbyopia
Jacksonville, Florida, United States
View Trial DetailsNCT06864858
Visual Acuity
Maitland, Florida, United States
View Trial DetailsNCT07443215
Visual Acuity
Jacksonville, Florida, United States
View Trial Details