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Completed

NCT Number: NCT03183089

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

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.

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Key information

Conditions

Dry Eye Syndromes Dry Eye Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rohto Dry-Aid®

Drug

Systane® Ultra

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Mentholatum Company

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2017
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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