Back to resultsComparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye
Primary Purpose
Dry Eye Syndromes, Dry Eye
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rohto Dry-Aid®
Systane® Ultra
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active
Active Comparator
Arm Description
Outcomes
Primary Outcome Measures
Dry Eye Staining
Dry eye syndrome corneal and conjunctival staining assessment
Dry Eye Symptom Questionnaire
Symptom assessment questionnaire
Tear Film Break Up Time
Tear Film Break Up Time after instillation of fluorescein dye
Visual Function Assessment
Reading Test
Secondary Outcome Measures
Drop Comfort Assessment
The comfort of the eye drop will be performed to assess changes from baseline
Visual Acuity
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Slit-Lamp Biomicroscopy
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline
Adverse Event
Adverse Event queries
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183089
Brief Title
Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
January 4, 2016 (Actual)
Study Completion Date
January 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mentholatum Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Active Comparator
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rohto Dry-Aid®
Intervention Type
Drug
Intervention Name(s)
Systane® Ultra
Primary Outcome Measure Information:
Title
Dry Eye Staining
Description
Dry eye syndrome corneal and conjunctival staining assessment
Time Frame
28 days
Title
Dry Eye Symptom Questionnaire
Description
Symptom assessment questionnaire
Time Frame
28 days
Title
Tear Film Break Up Time
Description
Tear Film Break Up Time after instillation of fluorescein dye
Time Frame
28 days
Title
Visual Function Assessment
Description
Reading Test
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Drop Comfort Assessment
Description
The comfort of the eye drop will be performed to assess changes from baseline
Time Frame
Day 1
Title
Visual Acuity
Description
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Time Frame
28 Days
Title
Slit-Lamp Biomicroscopy
Description
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline
Time Frame
28 Days
Title
Adverse Event
Description
Adverse Event queries
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Torkildsen, M.D.
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye
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