A prospective, randomized, parallel design study to prove the superiority of Xalost S eye drops compared to RysmonTG eye drops 0.25% in the aspects of optic disc and macular vessel density in subjects with open-angle glaucoma and ocular hypertensio
- Conditions
- Diseases of the eye and adnexa
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 180
1.Those who aged 19 or order and who willing to comply with all treatment and follow-up test procedures.
2.Those who diagnosed OAG(Primary Open Angle Glaucoma[POAG], pigmentary glaucoma, pseudoexfoliative glaucoma) or OHT
3.Those who with a maximum calibration vision of +0.60 logMAR or less(Snellen equivalent of 20/80 or more) in each eye
4.Those who with central Corneal Thickness = 480 µm and = 600 µm in each eye
5.Those who with 2grade or more grade(Shaffer scales) of gonioscopy
6.Subjest must meet the following criteria at the time of their second visit(baseline)
-Completed the required standby/restraint period.
-All IOP results are 25mmHg or less in each eyes
1.A woman who is pregnant, breastfeeding, or planning to conceive.
2.Those who disagrees with contraception among female childbearing patients during the clinical trial period.
3.Subject to test for known or suspected abuse of drugs or alcohol.
4.Those who are currently participating or planning to participate in other clinical trials related to clinical drugs or medical devices within 4 weeks prior to the first visit (screening) or at any time during this trial period.
5. Those who intend to use the following prohibited drugs during the test period or are currently using them.
*sodium chloride/ potassium chloride eye drops, anti-cataract agent(e.g., Glutathione, pirenoxine, Vitamin B12(ex. cyanocobalamine])), all eye drops except for IPs
*All systemic IOP reducers (e.g., oral or intravenous CAI, oral glycerol).
*All eyes, around the eyes, inhalation, nasal or systemic corticosteroids.
6. Those who cannot safely discontinue the use of intraocular pressure reducer during the atmospheric/rest period.
7.Any systemic or topical drug known to affect IOP(e.g., ß-adrenaline antagonists, ß-adrenaline agents, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor blockers (ARB]) to be tested or controlled.)
8.Patient with the past history of corneal refractive correction surgery in either way.
9.Patient with the history of specific ophthalmic surgery (e.g., laser fibroblast, filtration, minimally invasive glaucoma surgery (MIGS) or fibroblastotomy) to lower IOP in either eye.
10.Patient with past history of corneal refractive correction surgery in either eye.
11.Those who has allergies, hypersensitivities, or prohibition about Prostaglandin, benzalkonium chloride (BAK) or any other components in Investigational Products, or any other procedures/drugs for any tests in this Clinical trial
12.Any eyes that have active Glaucoma (Ex. Below -12 dB of mean deviation of visual field test
13.Any eyes that have cornea abnormalities or status that can interrupt or block measuring Goldman’s applanation tonometer with reliability (Ex. Fuchs Endothelial Corneal Dystrophy, FECD or any other abnormalities with clinically significant)
14. Any eyes that have active serious corneal and anterior segment diseases, inflammation, or eye and/or eyelid infection in either eye.
15. Any eyes that have Macular edema with clinically significant
16.Any eyes that have had medical history of serious external injuries
17.Any eyes that have had medical history of iritis and/or uveitis
18.Any eyes that have medical history of Retinal Detachment, proliferative diabetic retinopathy (PDR), or any other Retinal diseases that may have progressed over the time course of the trial.
19.Those who are ineligible to participate in clinical trials for the reason of any medical issues as judged by the investigators .
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change of vessel density in optic disc and macular
- Secondary Outcome Measures
Name Time Method the change of ocular hypertension