Test lens
Devicecontact lens
Other names: Invigor I DD lens, Somofilcon A 1 day Test
NCT Number: NCT03951610
The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University Eye Center at Ketchum Health, Anaheim, California, United States
The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
contact lens
Other names: Invigor I DD lens, Somofilcon A 1 day Test
contact lens
Other names: Clariti 1-day, Somofilcon A 1 day control
Time frame: Baseline
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time frame: 1 week
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time frame: Baseline
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time frame: 1 week
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time frame: baseline
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time frame: 1 week
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time frame: Baseline
Up Gaze Lag (measured in mm at 0.1mm steps)
Time frame: 1 week
Up Gaze Lag (measured in mm at 0.1mm steps)
Time frame: baseline
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time frame: 1 week
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time frame: Baseline
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time frame: 1 week
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time frame: Baseline
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time frame: 1 week
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time frame: Baseline
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time frame: 1-week
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
CooperVision, Inc.
Industry
A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
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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