NCT03614130

Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.

Detailed description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	LID011121 contact lens	Investigational silicone hydrogel contact lens
DEVICE	Comfilcon A contact lens	Commercially available silicone hydrogel contact lens

Timeline

• Start date: 2018-08-23
• Primary completion: 2018-09-11
• Completion: 2018-09-11
• First posted: 2018-08-03
• Last updated: 2021-09-30
• Results posted: 2021-09-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study