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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-03

Study Completion Date

2016-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Syndromes Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

Rohto Dry-Aid®

Intervention Type DRUG

Active Comparator

Group Type ACTIVE_COMPARATOR

Systane® Ultra

Intervention Type DRUG

Interventions

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Rohto Dry-Aid®

Intervention Type DRUG

Systane® Ultra

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No