Trials / Completed
CompletedNCT03722784
Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- CooperVision, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.
Detailed description
This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Invigor A (test) | silicone hydrogel lens |
| DEVICE | Invigor B (control) | silicone hydrogel lens |
Timeline
- Start date
- 2018-10-10
- Primary completion
- 2019-01-18
- Completion
- 2019-06-01
- First posted
- 2018-10-29
- Last updated
- 2020-10-01
- Results posted
- 2020-10-01
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03722784. Inclusion in this directory is not an endorsement.