Indiana University School of Optometry
Bloomington, Indiana, 47405, United States
NCT Number: NCT05035017
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
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Notify Me18 year and older
All sexes
Interventional
Bloomington, Indiana, 47405, United States
This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily disposable with modified lens design for 2 days
Daily disposable lens for 2 days
Time frame: 2 days
Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.
Time frame: 2 days
Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision.
Time frame: 2 days
Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum
Time frame: 2 days
Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling.
Time frame: 2 days
Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately.
CooperVision, 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.
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