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NCT02886923

Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Completed NA Results posted Last updated 20 December 2019
What this trial tests

NA trial testing Hioxifilcon A Test in Refractive Error in 24 participants. Completed in 23 January 2017.

Timeline
1 August 2016
Primary endpoint
23 January 2017
23 January 2017

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment24
Start date1 August 2016
Primary completion23 January 2017
Estimated completion23 January 2017
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

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.

GroupValue95% 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.

GroupValue95% 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.

GroupValue95% 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.

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Other recruiting trials for Refractive Error

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02886923.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing