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

• Status: Completed
• Trial end date: 2016-01-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Mentholatum Company

Criteria

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