Trials / Completed
CompletedNCT04403542
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (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 when worn continuously for up to 1 week.
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 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lehfilcon A contact lens | Investigational silicone hydrogel contact lens |
| DEVICE | Comfilcon A contact lens | Commercially available silicone hydrogel contact lens |
Timeline
- Start date
- 2020-08-03
- Primary completion
- 2020-08-31
- Completion
- 2020-08-31
- First posted
- 2020-05-27
- Last updated
- 2023-08-22
- Results posted
- 2023-08-22
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04403542. Inclusion in this directory is not an endorsement.