Trials / Completed
CompletedNCT02537717
A Contralateral Dispensing Clinical Trial of Study Test Silicone Hydrogel Lens Against Enfilcon A Silicone Hydrogel Lens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- CooperVision, Inc. · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Accepted
Summary
This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.
Detailed description
Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sapphire Lens | Each subject randomized to wear either the test or control in either the left of right eye. |
| DEVICE | enfilcon A | Each subject randomized to wear either the test or control in either the left of right eye. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2015-12-01
- Completion
- 2016-04-29
- First posted
- 2015-09-02
- Last updated
- 2020-11-19
- Results posted
- 2020-10-27
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02537717. Inclusion in this directory is not an endorsement.