Investigation on the Efficacy and Safety of the Combination Therapy of Prostaglandin Analogs and Brimonidine/Timolol Fixed Combination

JRCT ID: jRCTs051190125

Registered date:27/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Open angle glaucoma (primary open angle glaucoma or exfoliation glaucoma), ocular hypertension
• Date of first enrollment: 04/04/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): One drop of BTFC or DTFC is instilled twice-daily (in the morning and in the evening) for 8 weeks each.

Outcome(s)

• Primary Outcome: Changes in IOP (the average values of hour 0 and hour 2)
• Secondary Outcome: Changes of IOP (hour 0, hour 2), rate of IOP change, IOP, adverse events, corrected visual acuity, ophthalmologic findings, fundus, sense of use

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with written informed consent obtained after adequate explanation on participating the study
2)Male or female outpatient, 20 years of age or older
3)Patients with open angle glaucoma (primary open angle glaucoma or exfoliation glaucoma) or ocular hypertension in the study eye
4)Patients who have continued to instill the same prostaglandin analog into the study eye more than 90 days
5)Patients with IOP between 15.0 mmHg and 24.0 mmHg in the study eye at the initiation of the evaluation period (Visit1)
6)Patients with IOP range within 3 mmHg in past 90 days in the case of exfoliation glaucoma
7)Patients with required additional IOP-lowering treatment
8)Patients with IOP of 24.0 mmHg or lower for both eyes
9)Patients with best corrected visual acuity of 0.3 or better for both eyes

Exclude criteria

1)Patients who have instilled the drug for glaucoma except prostaglandin analogs in the study eye or have used corticosteroid agent within past 28 days of Visit1
2)Patients with history of surgery for glaucoma with the study eye
3)Patients with history of intraocular surgery within past 90 days of Visit1 with the study eye
4)Patients with intraocular injection, sub-Tenon or subconjunctival injection of a triamcinolone acetonide within past 180 days of Visit1 with the study eye
5)Patients with any active retinal disease which may progress during the study in the eye instilled with test drug
6)Patients with any active ocular disease other than primary open-angle glaucoma or ocular hypertension in the eye instilled with test drug
7)Patients with a serious systemic disease
8)Patients with severe visual field defect with the study eye
9)Patients with corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer with the study eye
10)Patients with history of corneal transplantation or keratorefractive surgery with the study eye
11)Patients with contraindications or patients in whom precautions are required for the use of BTFC or Dorzolamide/Timolol fixed combination (DTFC)
12)Women who are pregnant, lactating or may be pregnant, or planning to be pregnant during the study period, or cannot agree to contraception
13)Patients who have been administered investigational drug within past 90 days of Visit1
14)Patients who are planning to receive prohibited concomitant drugs during the study period
15)Patients who have been considered inappropriate as study subjects by doctor

Related Information

• Primary Sponsor: Inatani Masaru
• Secondary Sponsor: Senju Pharmaceutical Co.,Ltd.