An Open-Label, Single-Center Study to Evaluate Symptom Response and Tear Film Cooling Dynamics of Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)

NCT02985827 Phase 4 COMPLETED Results posted

The purpose of the study is to analyze the sensation to eye drops containing menthol in people with healthy eyes and in people with dry eyes. This study also examines the temperature of your eye using an Infrared Camera.

Details

Lead sponsor	ORA, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	48
Start date	2015-12
Completion	2016-01

Conditions

• Dry Eye

Interventions

• Rohto (r) Hydra
• Systane (r) Ultra

Primary outcomes

• Sum of the Cooling Scale For Rohto (r) Hydra — 4 Minutes
  Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.