NCT04885296

Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

Completed NA Results posted Last updated 1 September 2022

What this trial tests

NA trial testing TRP-200 in Visual Acuity in 228 participants. Completed in 9 August 2021.

Timeline

10 May 2021

Primary endpoint
9 August 2021

9 August 2021

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	228
Start date	10 May 2021
Primary completion	9 August 2021
Estimated completion	9 August 2021
Sites	12 locations across United States

Drugs / interventions tested

• TRP-200
• JJVC Marketed Contact Lens

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.

Overall Quality of Vision Score Primary · 2-Week Follow-up

Overall quality of vision scores were 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

Group	Value	95% CI
Test (Senofilcon A C3)	69.3	± 20.84
Control (Senofilcon A C3)	69.0	± 22.12

Overall Comfort Scores Secondary · 2-Week Follow-up

Overall comfort scores were 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 comfort score for each lens type was

Group	Value	95% CI
Test (Senofilcon A C3)	68.1	± 24.58
Control (Senofilcon A C3)	69.0	± 24.08

Overall Handling Scores Secondary · 2-Week Follow-up

Overall handling scores were 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 handling score for each lens type w

Group	Value	95% CI
Test (Senofilcon A C3)	66.9	± 23.94
Control (Senofilcon A C3)	68.6	± 22.72

Sponsor's own description

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Publications & conference data

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