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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03183089
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Dry Eye Drug: Rohto Dry-Aid® Drug: Systane® Ultra Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : January 4, 2016
Actual Study Completion Date : January 4, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

Arm Intervention/treatment
Experimental: Active Drug: Rohto Dry-Aid®
Active Comparator: Active Comparator Drug: Systane® Ultra

Primary Outcome Measures :
  1. Dry Eye Staining [ Time Frame: 28 days ]
    Dry eye syndrome corneal and conjunctival staining assessment

  2. Dry Eye Symptom Questionnaire [ Time Frame: 28 days ]
    Symptom assessment questionnaire

  3. Tear Film Break Up Time [ Time Frame: 28 days ]
    Tear Film Break Up Time after instillation of fluorescein dye

  4. Visual Function Assessment [ Time Frame: 28 days ]
    Reading Test

Secondary Outcome Measures :
  1. Drop Comfort Assessment [ Time Frame: Day 1 ]
    The comfort of the eye drop will be performed to assess changes from baseline

  2. Visual Acuity [ Time Frame: 28 Days ]
    Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

  3. Slit-Lamp Biomicroscopy [ Time Frame: 28 Days ]
    Slit lamp biomicroscopy exams will be performed to assess any changes from baseline

  4. Adverse Event [ Time Frame: 28 Days ]
    Adverse Event queries

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03183089

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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
The Mentholatum Company
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Principal Investigator: Gail L Torkildsen, M.D. Andover Eye Associates
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Responsible Party: The Mentholatum Company Identifier: NCT03183089    
Other Study ID Numbers: 15-110-0011
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases