A Phase IV Clinical Trial to Evaluate the Safety and Efficacy of SYSTANEHYDRATION in Indian Subjects with Dry Eye

Alcon Research Ltd0 sites177 target enrollmentTBD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: H049- Disorder of lacrimal system, unspecified
Sponsor: Alcon Research Ltd
Enrollment: 177
Status: Active, not recruiting
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Pms

Sponsor

•1\. Male or female adults aged \>18 years and \<65 years of age;
•2\. Subject must be willing to participate in the study and should understand and sign an informed consent form (ICF) that has been approved by Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC);
•3\. BCVA of \>\=20/40 in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart;
•4\. DEQ\-5 score \>\=6;
•5\. TBUT \<\=10 seconds in both eyes;
•6\. Average TOSS score \>\=4 (based on the 15\-point Oxford grading scheme);
•7\. Subject is otherwise healthy and medically stable on the basis of medical history at screening (based on the investigatorâ??s medical
•8\. Male and female subjects of childbearing potential willing to practice appropriate birth control methods during the entire duration of the study. Appropriate birth control methods include
•tubal ligation, transdermal contraceptive patch, intra uterine devices/systems, oral, implantable, or injectable contraceptives, sexual abstinence, double\-barrier methods, and vasectomized partner.

•1\. Women of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 1 year) are excluded from participating in the study if they meet any of the following conditions:
•a. They are currently pregnant or planning to be pregnant during the study, or
•b. They have a positive result on a urine pregnancy test (human chorionic gonadotropin) at the Screening Visit, or
•c. They are breast feeding;
•2\. Contraindications or hypersensitivities to any of the components of the study treatment;
•3\. Evidence of the following within 30 days prior to the Screening Visit:
•a. Ocular infection (bacterial, viral, or fungal)
•b. Ocular inflammation including, but not limited to:
•i. Inflammation of the anterior or posterior segments
•ii. Active allergic conjunctivitis