NCT03706443

Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations.

Detailed description

This study will objectively evaluate two US lubricant eye drop formulations produced by Alcon, INC. Systane® Ultra, a non-emollient eye drop, will be compared to Systane® Complete, an emollient eye drop, 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, 2, 4 and 6 hours after each eye drop has been instilled. Non-invasive measurements of tear break-up time will be also conducted at each visit. Subjects will then be dispensed the emollient eye drop (Systane® Complete) for use four times daily for one month and return to the study site for final measurements of dry eye symptoms, lipid layer thickness, and tear break-up time. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement, and the Oculus Keratograph (K5M) is used for non-invasive measurements of tear break-up time.

Conditions

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Lacrimal Apparatus Diseases
• Keratoconjunctivitis
• Eye Diseases
• Keratitis
• Corneal Disease
• Ophthalmic Solution

Interventions

Type	Name	Description
OTHER	Systane Complete	Lubricant eye drop which is based on propylene glycol 0.6%. Used for temporary relief of burning and irritation due to dryness of the eye.
OTHER	Systane Ultra	Lubricant eye drop which is based on polyethylene glycol 400 0.4% and propylene glycol 0.3%. Used for temporary relief of burning and irritation due to dryness of the eye.

Timeline

• Start date: 2018-12-05
• Primary completion: 2019-02-28
• Completion: 2019-02-28
• First posted: 2018-10-16
• Last updated: 2019-05-23

Locations

1 site across 1 country: United States