NCT05021081

Visual Performance of Senofilcon A With and Without a New UV/HEV-filter

Completed NA Results posted Last updated 26 January 2023

What this trial tests

NA trial testing TRP-200 in Visual Performance in 82 participants. Completed in 20 October 2021.

Timeline

23 August 2021

Primary endpoint
20 October 2021

20 October 2021

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	82
Start date	23 August 2021
Primary completion	20 October 2021
Estimated completion	20 October 2021
Sites	1 location across United States

Drugs / interventions tested

• TRP-200
• ACUVUE Oasys 1-Day

Conditions studied

• Visual Performance — all drugs for Visual Performance →

Sponsor

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

Who can join

Adults 18 to 70, any sex, with Visual Performance. 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.

Photopic Contrast Sensitivity at 6 Cpd Primary · Post screening up to 1 hour during Phase 1

Photopic (\~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.

Group	Value	95% CI
With Glare	1.46	± 0.317
Without Glare	1.91	± 0.373

Mesopic Contrast Sensitivity at 6 Cpd Primary · Post screening up to 1 hour during Phase 1

Mesopic (\~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.

Group	Value	95% CI
With Glare	0.70	± 0.328
Without Glare	1.29	± 0.498

Photopic Resolution Acuity Using Landolt C's With a Glare Source Primary · At least 5 minutes post lens fitting up to 2 hours during Phase 2

Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (\~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.

Group	Value	95% CI
Test (Senofilcon A C3)	0.01	± 0.191
Control (Senofilcon A C3)	-0.01	± 0.158

Photopic Contrast Sensitivity With a Glare Source Secondary · At least 5 minutes post lens fitting up to 2 hours during Phase 2

Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (\~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.

Group	Value	95% CI
Test (Senofilcon A C3)	1.18	± 0.248
Control (Senofilcon A C3)	1.21	± 0.250

Mesopic Contrast Sensitivity With a Glare Source Secondary · At least 5 minutes post lens fitting up to 2 hours during Phase 2

Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.

Group	Value	95% CI
Test (Senofilcon A C3)	0.71	± 0.212
Control (Senofilcon A C3)	0.72	± 0.232

Sponsor's own description

This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.