Primary open-angle glaucoma (broad definition) or ocular hypertension
Conditions
Interventions
Enrolled patients are randomlly assigned to either of the following two groups after giving their consent
Group A: lipasudil and brimonidine ophthalmic suspension (GRA-ALPHA combination ophthalmic suspension)
Group B: dorzolamide/timolol ophthalmic solution (COSOPT ophthalmic solution or RORMOLOL combinat
Sponsors
Honjo Megumi
Aihara Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who understand the contents of the informed consent documet of this study, and give written consent to pariticipate in this study by their free will. 2. Male or female who aged 18 years or older at giving their consent. 3. Patients who are diagnosed with primary open-angle glaucoma (in broad definition) or ocular hypertension. 4. Patients who received prostanoid receptor agonist (FP receptor agonist, EP2 receptor agonist) alone for 4 cibsecutive weeks or longer prior to giving their consent. 5. Patients who require additional treatment due to ocular pressure of at least one eye or 15mmHg or higher at giving their consent
Exclusion criteria
Exclusion criteria: 1. Patients with history or complication of bronchial asthma, bronchospasm, or severe chronic obstructive pulmonary disease 2. Patients with unstable heart failure, sinus bradycardia, atrioventricular block (degree II or III), cardiogenic shock, right heart failure due to pulmonary hypertension, or congestive heart failure 3. Patients with hypersensitivity to any component of study agent in this study 4. Patients with severe renal impairment 5. Patients with diabetic ketoacidosis and metabolic acidosis 6. Patients with inadequately controlled diabetes mellitus 7. Patients with hepatic impairment 8. Patients with cerebrovascular disorders or orthostatic hypotension 9. Patients with cardiovascular disease 10. Patients with history or complication of chronic or recurrent severe ocular inflammatory disease (scleritis, uveitis, herpes keratitis) in any eye 11. Patients with history of ocular trauma within 6 months prior to giving their consent in the study eye 12. Patients with complication of ocular infection or endophthalmitis in any eye 13. Patients with history or complication of clinically problematic or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, or retinal detachment) in any eye 14. Patients who received endophthalmic surgery within 6 months prior to giving their consent in the study eye 15. Patients who received ophthalmic laser surgery within 3 months prior to giving their consent in the study eye 16. Patients whose study eye has difficulty measuring intraocular pressure with a plain tonometer 17. Patients with best corrected visual acuity (fractional visual acuity) of 0.2 or less in the study eye 18. Patients with a corner angle grade of 2 or less according to the Shaffer classification in the study eye 19. Patients with significant visual field impairment that the responsible investigator or subinvestigator determines to be inappropriate to participate in the study 20. Patients who cannot safely discontinue the use of ophthalmic or systemic corticosteroids until completion of treatment with the study agent or control agent 21. Wommen who are pregnant, breastfeeding, or planning to be pregnant 22. Patients who have participated or currently participating in another clinical study within 30 days prior to giving their consent 23. Patients who are judged by the responsible investigator or subinvestigator to be inappropriate to participate in this study due to history of serioud disease or current health condition, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ocular pressure of 2 hours after the eydrop from baseline to week 4 or 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in ocular pressure of before the eyedrop from baseline to week 4 or 8 - Change in blood pressure of before the eyedrop from baseline to week 4 or 8 - Change in pulse rate of before the eyedrop from baseline to week 4 or 8 - Questionnaire about the usability of the eydrop - Frequency of adverse event or disease-or-the-like | — |
Contacts
Public ContactMegumi Honjo
Yotsuya Shirato Ophthalmology Clinic
Outcome results
None listed