Trials / Completed
CompletedNCT03380624
Tear Lipid Layer Thickness With Emollient Eye Drops
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Ohio State University · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Accepted
Summary
Crossover comparison of lipid layer thickness with two artificial tear formulations
Detailed description
This study will objectively evaluate two US Monograph lubricant eyedrop formulations (Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with additional compendial ingredients (Refresh Optive MEGA 3) in subjects with dry eye symptoms and lipid layer thickness \< 75 nm at baseline in a randomized, cross-over (masked subject) design. We seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Refresh Optive | Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose |
| DRUG | Refresh Optive MEGA-3 | Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2018-06-30
- Completion
- 2018-06-30
- First posted
- 2017-12-21
- Last updated
- 2021-02-03
- Results posted
- 2021-02-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03380624. Inclusion in this directory is not an endorsement.