A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye

• Sponsor: Seikagaku Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01558999
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: High concentration SI-614; Drug: Low concentration SI-614; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High concentration SI-614	Drug: High concentration SI-614; 1 drop in each eye 4 times a day
Experimental: Low concentration SI-614	Drug: Low concentration SI-614; 1 drop in each eye 4 times a day
Placebo Comparator: Vehicle	Drug: Vehicle; 1 drop in each eye 4 times a day

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline in TFBUT [Day 27]

2. Mean change from baseline in symptom score [Day 21 - 27]

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

• Have provided written informed consent

• Have dry eye in both eyes

Exclusion Criteria:

• Use of contact lenses

• Have an uncontrolled systemic disease

• Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse

• Women who is pregnant, nursing or planning a pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SKK Investigational Site	Andover	Massachusetts	United States

Sponsors and Collaborators

• Seikagaku Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seikagaku Corporation
• ClinicalTrials.gov Identifier: NCT01558999
• Other Study ID Numbers: 614/1121
• First Posted: Mar 20, 2012
• Last Update Posted: Jul 24, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jul 24, 2014