Study to Evaluate the Efficacy and Safety of CKD-350

Launched by CHONG KUN DANG PHARMACEUTICAL · May 17, 2016

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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