A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04084483
• Collaborator: (none)
• Enrollment: 238
• Locations: 4
• Arms: 4
• Actual Duration (Months): 5.2
• Patients Per Site: 59.5
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: K-161; Other: Placebo (Vehicle)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
• Actual Study Start Date: Aug 4, 2019
• Actual Primary Completion Date: Jan 9, 2020
• Actual Study Completion Date: Jan 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 K-161 Ophthalmic Solution Dose A.	Drug: K-161; K-161 alternate dosage
Experimental: Group 2 K-161 Ophthalmic Solution Dose B.	Drug: K-161; K-161 alternate dosage
Experimental: Group 3 K-161 Ophthalmic Solution Dose C.	Drug: K-161; K-161 alternate dosage
Placebo Comparator: Group 4 Vehicle Solution Dose.	Other: Placebo (Vehicle); Placebo solution

Outcome Measures

Primary Outcome Measures

1. Change in Inferior Corneal Staining [29 Days]

   K-161 compared to Vehicle

2. Change in Ocular Discomfort [29 Days]

   Questionnaire

Secondary Outcome Measures

1. Change in Schirmer's Test value [29 Days]

2. Change in Tear Film break-up Time (TFBUT) [29 Days]

3. Number of Participants with Treatment Emergent Adverse Events [29 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age at the time of informed consent visit.

• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.

• Meet all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

• Have any clinically significant ocular condition.

• Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months.

• Must not meet any other exclusion criteria outlined in the clinical study protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Research Foundation	Newport Beach	California	United States	92663
2	Central Maine Eye Care	Lewiston	Maine	United States	04240
3	Andover Eye Associates	Andover	Massachusetts	United States	01810
4	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT04084483
• Other Study ID Numbers: K-161-2.01US
• First Posted: Sep 10, 2019
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Mar 26, 2021