CompletedInterventionalPhase 2Updated Mar 18, 2022
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye | NCT01558999 | Trialant
CompletedInterventionalPhase 2Updated May 11, 2023
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
ClinicalTrials.gov ID
NCT01558999
Lead Sponsor
Seikagaku CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
150Actual
Last Update Posted
May 11, 2023Actual
Start Date
Mar 2012
Primary Completion Date
Jul 2012Actual
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
Dry Eye Syndromes
High concentration SI-614
Low concentration SI-614
Vehicle
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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