NCT04085328

Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 675 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Detailed description

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Conditions

• Refractive Ametropia

Interventions

Type	Name	Description
DEVICE	LID015385 soft contact lenses	Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
DEVICE	Comfilcon A soft contact lenses	Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

Timeline

• Start date: 2019-10-11
• Primary completion: 2021-03-26
• Completion: 2021-03-26
• First posted: 2019-09-11
• Last updated: 2023-06-13
• Results posted: 2023-06-13

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated device study