Study to Evaluate the Efficacy and Safety of CKD-350

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Isotonic 0.3% Sodium Hyaluronate; Drug: Xenobella

Study type: Interventional

Funder types: Industry

Identifiers

NCT02777723

164DES16001

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome

Full description

Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome

Enrollment: 138 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. More than the age of 19 years old
2. Subjects with dry eye symptoms for at least 3 month prior to screening
3. Subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of Tear Break-up Time 3) ≤10mm/5min of Schirmer I Test
4. Subjects who have a visual acuity equal to or better than 0.2 in both eyes
5. Subjects who sign on an informed consent form willingly

Exclusion criteria

1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
2. Subjects who have medical history following 1) Abnormal eyelids function including abnormality of eyelid or eyelash 2) Ophthalmology operation within 1 year 3) Active ocular infection at present or treatment of allergic eye diseases 4) Herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus
3. Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial
4. Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study
5. Subjects who take steroidal or immunosuppressive drug within 1 month
6. Over 22mmHg IOP(Intraocular Pressure)
7. Subjects who have malignant tumor within 5 years
8. Subjects with known hypersensitivity to investigational product
9. Women who are nursing, pregnant or planning pregnancy during the study
10. Subjects who have received any other investigational product within 1 month prior to the first dosing
11. Impossible subjects who participate in clinical trial by investigator's decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

138 participants in 2 patient groups

CKD-350

Experimental group

Description:

Xenobella

Treatment:

Drug: Xenobella

Sodium Hyaluronate

Active Comparator group

Description:

Isotonic 0.3% Sodium Hyaluronate

Treatment:

Drug: Isotonic 0.3% Sodium Hyaluronate