NCT03605303

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions

• Refractive Error Correction

Interventions

Type	Name	Description
DEVICE	Test/Control	Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments
DEVICE	Control/Test	Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments

Timeline

• Start date: 2018-07-03
• Primary completion: 2018-07-05
• Completion: 2018-07-05
• First posted: 2018-07-30
• Last updated: 2019-08-28
• Results posted: 2019-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study