NCT03466060

Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.

Conditions

• Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)

Interventions

Type	Name	Description
DEVICE	Opti-Free : RevitaLens / Clear Care : RevitaLens	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	Opti-Free : RevitaLens / RevitaLens : Clear Care	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	Clear Care : RevitaLens/ Opti-Free : RevitaLens	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	Clear Care : RevitaLens / RevitaLens : Opti-Free	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	RevitaLens : Clear Care/ Opti-Free : RevitaLens	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	RevitaLens : Clear Care / RevitaLens : Opti-Free	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	RevitaLens : Opti-Free / Clear Care : RevitaLens	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICE	RevitaLens : Opit-Free / RevitaLens : Clear Care	Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

Timeline

• Start date: 2018-02-07
• Primary completion: 2018-06-19
• Completion: 2018-06-19
• First posted: 2018-03-15
• Last updated: 2019-10-02
• Results posted: 2019-10-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study