None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male or female patients aged 19-65 at the screening visit. (2) Patients who have typical dry eye symptoms including pruritus, foreign body sensation, pain, dryness, blurry eye, dazzle, eye congestion, and illacrimation, and whose ocular surface disease index (OSDI) score is =13. (3) The result of Schirmer ? test is =10 mm/5 min. (4) Patients with tear film break-up time (TFBUT) of = 10 seconds. (5) Patients who voluntarily submitted written consent.
Exclusion criteria
Exclusion criteria: (1) Dry eye syndrome caused by eyelids or eyelashes. (2) Irritated eye caused by acute inflammation arising from the eyelid, eyeball, or ocular appendage. (3) Patients who have secondary dry eye due to scarring caused by irradiation, alkali burn, Stevens-Johnson syndrome, pemphigoid, etc. (4) Patients who are diagnosed with vitamin A deficiency. (5) Patients who have damages caused by injury of the eyeball or ocular appendage. (6) Patients who had an operation to the anterior segment of the eye or operation via the anterior eye including cataract or LASIK within recent 3 months. (7) Patients who have difficulty in blink due to facial palsy. (8) Patients who received punctal plug or punctal occlusion. (9) Patients who used anti-inflammatory drops, including cyclosporine, corticosteroids, or autoserotherapy, directly to the eye within recent 2 weeks. (10) Patients who have active ocular infections including anterior uveitis or anterior blepharitis. (11) Patients who have ocular allergy or who are receiving treatments for allergic eye diseases. (12) Patients who have viral conjunctivitis symptoms or who are receiving treatments for viral conjunctivitis. (13) Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes or who are diagnosed with glaucoma. (14) Patients who wore contact lenses within the recent two weeks or who have to wear contact lenses during the trial period. (15) Patients taking systemic corticosteroids or immunosuppressants. (16) Pregnant, lactating women, or women planning pregnancy. (17) Others whom investigators determined inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface disease index;Tear film break-up time | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms visual analog scale;Quality of life;Schirmer I test;Lactoferrin level in tears;Treatment satisfaction;Safety | — |
Countries
Korea, Republic of
Contacts
Dongshin University