Adults 35 to 42, any sex, with Refractive Error. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.Primary· 15 minutes post lens fit
Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.
Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Group
Value
95% CI
Hioxifilcon A (Test)
-0.03
± 0.754
Hioxifilcon A (Control)
0.33
± 0.656
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.Secondary· 15 Minutes post lens fitting
Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Group
Value
95% CI
Hioxifilcon A (Test)
-2.16
± 0.606
Hioxifilcon A (Control)
-1.69
± 0.727
The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.Secondary· 15 Minutes post lens fitting
Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Group
Value
95% CI
Hioxifilcon A (Test)
-1.29
± 0.673
Hioxifilcon A (Control)
-1.04
± 0.782
Sponsor's own description
Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 20 December 2019
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