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

The Mentholatum Company

Status and phase: Completed; Phase 4

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Drug: Systane® Ultra; Drug: Rohto Dry-Aid®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03183089

15-110-0011

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Active

Experimental group

Treatment:

Drug: Rohto Dry-Aid®

Active Comparator

Active Comparator group

Treatment:

Drug: Systane® Ultra