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

Phase 4

Completed

• Conditions: Dry Eye Syndromes; Dry Eye
• Interventions: Drug: Rohto Dry-Aid®; Drug: Systane® Ultra

• Registration Number: NCT03183089
• Lead Sponsor: The Mentholatum Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-03
• Primary Completion: 2016-01-04
• Study Completion: 2016-01-04
• Status Verified: 2017-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Rohto Dry-Aid®	-
Active Comparator	Systane® Ultra	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States