primary open-angle glaucoma, ocular hypertension, exfoliation glaucoma
Conditions
Interventions
Group A: Administer ripasudil-brimonidine fixed-dose combination comibination ophthalmic solution (GLA-ALPHA comibination ophthalmic solution) for 12 weeks
Group B: Administer brimonidine-brinzolamide
Sponsors
Ueno Morio
Sotozono Chie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study; 1. patients who understand the content document for this study and give their consent in written form by their free will 2. adults who aged of 18 years or older at consenting 3. patients diagnosed with primary open-angle glaucoma (in broad definition), ocular hypertension, or exfoliation glaucoma In case of patients diagnosed with exfoliation glaucoma, fluctuations of intraocular pressure during past three measurement including at consenting should be within 5 mmHg. 4. patients receiving combination drugs of prostanoid receptor-related drugs and beta-blockers alone for at least 4 weeks. If beta-blockers could not be used, patients receiving prostanoid receptor-related drugs (FP receptor agonists or EP2 receptor agonists) alone for at least 4 weeks could be included. 5. patients with an intraocular pressure level (at least in one eye) of 15 mmHg or higher and less than 30 mmHg at consenting, who require additional treatment
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study; 1. patients with hypersensitivity to any of the components of the study drugs 2. patients with cerebrovascular disorders or orthostatic hypotension 3. patients with cardiovascular disease 4. patients with corneal epithelial edema 5. patients with a history or current complication of scleritis, uveitis, herpes keratitis, or chronic/recurrent severe ocular inflammatory disease in the target eye in this study 6. patients with a history of ocular trauma in the target eye in this study within 6 months prior to consenting 7. patients with ocular infection or endophthalmitis in the target eye in this study 8. patients with current complication of clinically problematic progressive retinal disease in the target eye in this study 9. patients who have undergone intraocular surgery for the target eyes in this study within the 6 months prior to consenting or who are scheduled to undergo intraocular surgery during the study period 10. patients who have undergone ophthalmic laser surgery for the target eyes in this study within 3 months prior to consenting 11. patients whose eyes have difficulties in measuring their intraocular pressure by applanation tonometer 12. patients with significant visual field impairment that the investigator determines to be problematic for inclusion in the study. 13. patients who cannot safely discontinue the use of ophthalmic or systemic corticosteroids until the end of study intervention 14. pregnant or lactating women, or patients who plan to become pregnant during the study 15. patients who have participated or are currently participating in another clinical trial or clinical study within 30 days prior to consenting 16. patients who are judged by the investigators to be inappropriate for participation in this study due to a history of serious illness or health condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in intraocular pressure (at 2 hours after the eye drop) from visit 1 (baseline) to visit 2 (week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in intraocular pressure (at 2 hours after the eye drop) from visit 1 (baseline) to visit 3 (week 12) 2. Questionnaire (score evaluation of hyperemia, irritation, eye pain, and blurred vision) 3. Occurrence of adverse event and disease-or-the-like | — |
Contacts
Public ContactMorio Ueno
University Hospital Kyoto Prefectural University of Medicine
Outcome results
None listed