None listed
Conditions
Interventions
Drug : This is a prospective comparative clinical study evaluating the efficacy and safety of two ophthalmic agents in patients with dry eye disease characterized by short tear film break-up time (TBU
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adults aged 19 years or older at the time of screening. Have experienced at least one of the following dry eye symptoms for 6 months or longer prior to screening: Irritation Foreign body sensation Burning Mucus discharge Blurring Itching Photophobia Tired or heavy sensation Pain At screening and at the time of randomization, meet all of the following criteria in at least one eye: A. Tear break-up time (TBUT) = 5 seconds B. Ocular Surface Disease Index (OSDI) score = 23 C. Schirmer test without anesthesia = 5 mm/5 minutes At screening and at the time of randomization, the eye(s) eligible for the study must meet all of the following criteria: A. Intraocular pressure (IOP) between 5 mmHg and 21 mmHg B. Best corrected visual acuity (BCVA) of 0.2 or better (equivalent to +0.7 logMAR or Snellen 20/100) in all study eyes Have fully understood the clinical trial and provided written informed consent voluntarily to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects with ophthalmic diseases that may interfere with the interpretation of study results, such as clinically significant corneal surface disorders, abnormal corneal sensitivity, or excessive tear production (e.g., radiation or alkali burns, Stevens-Johnson syndrome [SJS], cicatrical pemphigoid, conjunctival goblet cell loss associated with vitamin A deficiency, or dry eye secondary to thyroid dysfunction). Subjects with severe eyelid disorders (e.g., blepharitis, eyelid laxity, ectropion, entropion) that are active or require treatment. Subjects with Meibomian gland dysfunction of Grade 2 or higher. Subjects with primary or secondary Sjögren’s syndrome (including rheumatoid arthritis, systemic lupus erythematosus, etc.) that is active or requires treatment. Subjects with ocular conditions other than dry eye disease that, in the investigator’s judgment, may affect the interpretation of study results (e.g., active uveitis, keratoconjunctivitis, glaucoma, keratoconus, pterygium). Subjects with the following medical history (including surgical history) within 1 year prior to screening: Organ or bone marrow transplantation Known immunodeficiency or history of human immunodeficiency virus (HIV) infection Uncontrolled diabetes despite adequate treatment (hemoglobin A1c [HbA1c] > 9%) Uncontrolled systemic diseases: i. Hypertension not controlled with antihypertensive therapy (systolic blood pressure [SBP]/diastolic blood pressure [DBP] > 160/100 mmHg) ii. Clinically significant cardiovascular or pulmonary disease not controlled with treatment History of or ongoing treatment for HBV, HCV, or HIV Subjects who, within 4 weeks prior to randomization, received or require administration of the following medications during the study period: Cyclosporine ophthalmic solution, rebamipide ophthalmic solution, or diquafosol ophthalmic solution Medications known to induce dry eye (e.g., anticholinergics, isotretinoin) Corticosteroids, mast cell stabilizers, antihistamines, anti-inflammatory drugs, gamma-linolenic acid or omega-3 fatty acid supplements, or antibiotics Any other ophthalmic medications (except artificial tears) within 3 days prior to screening Subjects with a history of ophthalmic surgery within 3 months prior to screening or with planned ophthalmic surgery during the study (e.g., punctal plug insertion, punctal occlusion, or posterior capsulotomy using Yttrium-Aluminum-Garnet [YAG] laser). Subjects who wore contact lenses within 1 week prior to screening or require contact lens use during the study. Subjects expected to receive rebamipide treatment due to gastrointestinal disorders or gastritis during the study period. Subjects with a history of myocardial infarction. Pregnant or breastfeeding women, or subjects who do not agree to use an appropriate medically acceptable method of contraception during the study. Subjects with a known hypersensitivity to the investigational product or its components. Subjects who participated in another clinical trial involving an investigational product or medical device within 4 weeks prior to screening. Subjects deemed, in the investigator’s judgment, unsuitable for participation in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Break-Up Time (TBUT) and Change from Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) and Change from Baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactHanbyul Yi
Gyeongsang National University Hospital
Outcome results
None listed