NCT05056870

Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Completed NA Results posted Last updated 27 April 2023

What this trial tests

NA trial testing ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism in Visual Acuity in 174 participants. Completed in 3 March 2022.

Timeline

15 September 2021

Primary endpoint
3 March 2022

3 March 2022

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	174
Start date	15 September 2021
Primary completion	3 March 2022
Estimated completion	3 March 2022
Sites	13 locations across United States

Drugs / interventions tested

• ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism
• ACUVUE Oasys 1-Day with HydraLuxe Technology

Conditions studied

• Visual Acuity — all drugs for Visual Acuity →

Sponsor

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

Who can join

Adults 18 to 39, any sex, with Visual Acuity. 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.

High Luminance High Contrast Monocular Visual Acuity (LogMAR) Primary · 1-Week Follow-up

Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type.

Group	Value	95% CI
Test (AO1DfA)	-0.126	± 0.0798
Control (AO1D)	-0.028	± 0.1123

CLUE Vision Score Secondary · 1-Week Follow-up

CLUE Vision Score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was report

Group	Value	95% CI
Test (AO1DfA)	69.39	± 20.151
Control (AO1D)	41.49	± 28.139

High Luminance High Contrast Monocular Visual Acuity (LogMAR) Secondary · 1-Week Follow-up

Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure o

Group	Value	95% CI
Test (AO1DfA)	-0.128	± 0.0799
Spectacles	-0.107	± 0.0812

Subjective Contact Lens Preference Secondary · 1-Week Follow-up

Prefer Test

Group	Value	95% CI
Total	0.689

Prefer Control

Group	Value	95% CI
Total	0.225

No Preference

Group	Value	95% CI
Total	0.086

Sponsor's own description

This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.

Publications & conference data

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