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

Sponsor
The Mentholatum Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03183089
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
76.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rohto Dry-Aid®
  • Drug: Systane® Ultra
 Phase 4

Study Design

Study Type:
Interventional
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 :
Dec 3, 2015
Actual Primary Completion Date :
Jan 4, 2016
Actual Study Completion Date :
Jan 4, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

Drug: Rohto Dry-Aid®
Active Comparator: Active Comparator

Drug: Systane® Ultra

Outcome Measures

Primary Outcome Measures

  1. Dry Eye Staining [28 days]

    Dry eye syndrome corneal and conjunctival staining assessment

  2. Dry Eye Symptom Questionnaire [28 days]

    Symptom assessment questionnaire

  3. Tear Film Break Up Time [28 days]

    Tear Film Break Up Time after instillation of fluorescein dye

  4. Visual Function Assessment [28 days]

    Reading Test

Secondary Outcome Measures

  1. Drop Comfort Assessment [Day 1]

    The comfort of the eye drop will be performed to assess changes from baseline

  2. Visual Acuity [28 Days]

    Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

  3. Slit-Lamp Biomicroscopy [28 Days]

    Slit lamp biomicroscopy exams will be performed to assess any changes from baseline

  4. Adverse Event [28 Days]

    Adverse Event queries

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andover Eye Associates Andover Massachusetts United States 01810

Sponsors and Collaborators

  • The Mentholatum Company

Investigators

  • Principal Investigator: Gail L Torkildsen, M.D., Andover Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Mentholatum Company
ClinicalTrials.gov Identifier:
NCT03183089
Other Study ID Numbers:
  • 15-110-0011
First Posted:
Jun 9, 2017
Last Update Posted:
Jun 9, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jun 9, 2017