Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye

A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye

The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Drug: Rohto Dry-Aid®; Drug: Systane® Ultra

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 18 years of age
• Provide written informed consent
• Have a reported history of dry eye
• Have a history of use of eye drops for dry eye symptoms
• Ocular discomfort
• Conjunctival redness
• Tear film break up time
• Corneal and Conjunctival Staining

Exclusion Criteria:

• Have any clinically significant slit lamp findings at entry visit
• Be diagnosed with an ongoing ocular infection
• Have any planned ocular and/or lid surgeries over the study period
• Have an uncontrolled systemic disease
• Be a woman who is pregnant, nursing or planning a pregnancy
• Be a woman of childbearing potential who is not using an acceptable means of birth control
• Have a known allergy and/or sensitivity to the test article or its components
• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Drug: Rohto Dry-Aid®
Active Comparator: Active Comparator	Drug: Systane® Ultra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dry Eye Staining	Dry eye syndrome corneal and conjunctival staining assessment	28 days
Dry Eye Symptom Questionnaire	Symptom assessment questionnaire	28 days
Tear Film Break Up Time	Tear Film Break Up Time after instillation of fluorescein dye	28 days
Visual Function Assessment	Reading Test	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop Comfort Assessment	The comfort of the eye drop will be performed to assess changes from baseline	Day 1
Visual Acuity	Visual Acuity will be measured using the EDTRS chart to assess changes from baseline	28 Days
Slit-Lamp Biomicroscopy	Slit lamp biomicroscopy exams will be performed to assess any changes from baseline	28 Days
Adverse Event	Adverse Event queries	28 Days

Collaborators and Investigators

• Sponsor: The Mentholatum Company
• Investigators: Principal Investigator: Gail L Torkildsen, M.D., Andover Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2015
• Primary Completion (Actual): January 4, 2016
• Study Completion (Actual): January 4, 2016

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 15-110-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No