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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183089
• Other study ID #: 15-110-0011
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2017
• Last updated: June 8, 2017
• Start date: December 3, 2015
• Est. completion date: January 4, 2016

Study information

• Verified date: June 2017
• Source: The Mentholatum Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 4, 2016
• Est. primary completion date: January 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Rohto Dry-Aid®

• Systane® Ultra

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The Mentholatum Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry Eye Staining	Dry eye syndrome corneal and conjunctival staining assessment	28 days
Primary	Dry Eye Symptom Questionnaire	Symptom assessment questionnaire	28 days
Primary	Tear Film Break Up Time	Tear Film Break Up Time after instillation of fluorescein dye	28 days
Primary	Visual Function Assessment	Reading Test	28 days
Secondary	Drop Comfort Assessment	The comfort of the eye drop will be performed to assess changes from baseline	Day 1
Secondary	Visual Acuity	Visual Acuity will be measured using the EDTRS chart to assess changes from baseline	28 Days
Secondary	Slit-Lamp Biomicroscopy	Slit lamp biomicroscopy exams will be performed to assess any changes from baseline	28 Days
Secondary	Adverse Event	Adverse Event queries	28 Days