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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedJune 9, 2017
June 1, 2017
1 month
June 6, 2017
June 8, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Drop Comfort Assessment
Day 1
Visual Acuity
28 Days
Slit-Lamp Biomicroscopy
28 Days
Adverse Event
28 Days
Study Arms (2)
Active
EXPERIMENTALActive Comparator
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail L Torkildsen, M.D.
Andover Eye Associates
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 9, 2017
Study Start
December 3, 2015
Primary Completion
January 4, 2016
Study Completion
January 4, 2016
Last Updated
June 9, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share