None listed
Conditions
Interventions
Drug : Experimental group: Cyclosporine 0.5 mg/mL ophthalmic solution will be instilled as one drop into each eye twice daily, approximately 12 hours apart.
Control group: RebaEye® ophthalmic solutio
Sponsors
Gyeongsang National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects aged 19 years or older at the time of screening 2.Subjects who have experienced at least one symptom of dry eye disease for 3 months or longer prior to screening, including but not limited to: -Blurred vision, photophobia, foreign body sensation (e.g., sandy or gritty feeling), ocular irritation, ocular pain or discomfort, and ocular itching 3.Subjects with a corneal fluorescein staining score of 3 or higher in at least one eye at screening and randomization 4.Subjects who meet at least one of the following criteria in the same eye at screening and randomization: -Schirmer test result (without anesthesia) = 10 mm/5 min -Tear break-up time (TBUT), measured by fluorescein staining, = 7 seconds -Ocular Surface Disease Index (OSDI) score of 13 or higher 5.Subjects with a best-corrected visual acuity (BCVA) of 0.2 or better in both eyes 6.Subjects who have voluntarily agreed to participate in this study and have provided written informed consent
Exclusion criteria
Exclusion criteria: ? Subjects who are currently using or have used ophthalmic cyclosporine or rebamipide formulations within 1 month prior to screening ? Subjects who are expected to require rebamipide treatment for gastrointestinal disorders or gastritis during the clinical trial period ? Subjects with clinically significant ophthalmic diseases not attributable to dry eye disease (e.g., corneal surface diseases, abnormal corneal sensitivity, excessive tearing) that may confound the interpretation of study results ? Subjects with any active ophthalmic diseases affecting the ocular surface, including active allergy, anterior uveitis, or Stevens–Johnson syndrome ? Subjects with elevated intraocular pressure or a diagnosis of glaucoma in at least one eye ? Subjects with autoimmune diseases (e.g., Sjögren’s syndrome) ? Subjects who have used acetylcysteine within 30 days prior to the screening visit ? Subjects with a history of myocardial infarction ? Subjects with a history of corneal transplantation or neurotrophic keratitis ? Subjects who have received ophthalmic medications or procedures for meibomian gland dysfunction (MGD) within 30 days prior to screening, or who are expected to require such treatments during the clinical trial period (Concomitant use of 0.5% carboxymethylcellulose [CMC] eye drops is permitted) ? Subjects receiving anti-inflammatory therapy for dry eye disease, such as autologous serum eye drops, within 30 days prior to screening ? Subjects who have taken antidepressants or hypnotic/sedative medications within 30 days prior to screening ? Subjects who have taken anticholinergic agents or antihistamines within 14 days prior to screening ? Subjects who have used topical steroid or non-steroidal anti-inflammatory ophthalmic agents within 14 days prior to screening, or systemic steroids* (oral, injectable, or implantable) or immunosuppressive agents within 3 months prior to screening For intraocular steroid injections or implants, subjects who received such treatment within 6 months prior to screening are excluded. ? Subjects with a history of ophthalmic surgery (e.g., LASIK, anterior segment surgery, or oular trauma) within 12 months prior to screening ? Subjects with a history of active hepatitis B or hepatitis C** Active hepatitis B is defined as the immune-active phase characterized by HBeAg positivity, fluctuating serum HBV DNA levels, and intermittent or persistent elevation of serum ALT. Hepatitis C history is defined as having received treatment for hepatitis C. ? Subjects with a history of malignancy (Participation is permitted if there has been no recurrence for at least 5 years following curative surgery.) ? Subjects diagnosed with uncontrolled hypertension or diabetes mellitus ? Subjects who have undergone silicone lacrimal punctal occlusion or punctal cauterization within 90 days prior to screening (Subjects who have undergone collagen lacrimal punctal occlusion are eligible.) ? Subjects who have worn contact lenses within 72 hours prior to screening or who are required to wear contact lenses during the clinical trial period ? Subjects who have participated in or are planning to participate in another interventional clinical trial within 30 days prior to screening ? Subjects with known hypersensitivity to any components of the investigational products (cyclosporine or rebamipide) ? Subjects diagnosed with psychiatric disorders that may affect participation or outcomes of this clinical trial ? Pregnant or breastfeeding women, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of changes in clinical signs and symptom scores at 4 weeks compared with baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of changes in clinical signs and symptom scores at 8 weeks compared with baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactHanbyul Yi
Gyeongsang National University Hospital
Outcome results
None listed