Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

• Sponsor: Santen Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01118754
• Collaborator: (none)
• Enrollment: 132
• Locations: 10
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 13.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: DE-101 ophthalmic suspension; Drug: DE-101 ophthalmic suspension; Drug: DE-101 ophthalmic suspension vehicle	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-101 ophthalmic suspension high dose	Drug: DE-101 ophthalmic suspension; Ophthalmic suspention; QID
Experimental: DE-101 ophthalmic suspension low dose	Drug: DE-101 ophthalmic suspension; Ophthalmic suspention; QID; Drug: DE-101 ophthalmic suspension; Ophthalmic suspension; QID
Placebo Comparator: DE-101 ophthalmic suspension vehicle	Drug: DE-101 ophthalmic suspension; Ophthalmic suspention; QID; Drug: DE-101 ophthalmic suspension vehicle; ophthalmic suspension vehicle; QID

Outcome Measures

Primary Outcome Measures

1. Total fluorescein corneal staining [8 weeks]

2. Ocular Symptom Severity [8 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• confirmed diagnosis of dry eye defined by protocol

• 18 years or older, and sign written informed consent

• negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion Criteria:

• use of any topical ocular medications

• any ocular surgery within 90 days of study

• laser refractive surgery within one year of study

• ocular, lid disease/abnormalities that may interfere with the study

• corneal transplants

• uncontrolled systemic conditions

• females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception

• participated in another drug trial within 30 days prior to study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Inglewood	California	United States
2		Torrance	California	United States
3		Bloomfield	Connecticut	United States
4		Indianapolis	Indiana	United States
5		New Albany	Indiana	United States
6		Gretna	Louisiana	United States
7		Bangor	Maine	United States
8		Cleveland	Ohio	United States
9		Philadelphia	Pennsylvania	United States
10		San Antonio	Texas	United States

Sponsors and Collaborators

• Santen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Inc.
• ClinicalTrials.gov Identifier: NCT01118754
• Other Study ID Numbers: 26-004
• First Posted: May 7, 2010
• Last Update Posted: Nov 3, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Santen Inc.: Santen; Dry; Eye
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Nov 3, 2011