ROCK inhibitor (ripasudil)-Alpha2 adrenoceptor agonist (brimonidine) fixed-dose combination ophthalmic solution v.s. Beta-blocker (timolol)-Carbonic anhydrase inhibitor (dorzolamide) fixed-dose combination ophthalmic solution comparison study on intraocular pressure lowering efficacy

JRCT ID: jRCTs031240193

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary open-angle glaucoma (broad definition) or ocular hypertension
• Date of first enrollment: 28/06/2024
• Target sample size: 114
• Study type: Interventional

Intervention(s)

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 combination ophthalmic solution)

Outcome(s)

• Primary Outcome: Change in ocular pressure of 2 hours after the eydrop from baseline to week 4 or 8

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Honjo Megumi
• Secondary Sponsor: Aihara Makoto
• Source(s) of Monetary Support: Kowa Company, Ltd.