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

Not Applicable

• Conditions: Open angle glaucoma (primary open angle glaucoma or exfoliation glaucoma), ocular hypertension; Open angle glaucoma, normal tension glaucoma, exfoliation glaucoma, ocular hypertension

• Registration Number: JPRN-jRCTs051190125
• Lead Sponsor: Inatani Masaru

Brief Summary

The concomitant use of BTFC with prostaglandin analogs lowered intraocular pressure by 3.55 mmHg, verifying that BTFC was non-inferior to DTFC. Tolerability is significantly higher in BTFC, and significantly more patients chose BTFC in regard to comfort compared to DTFC.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-27
• Study Completion: 2021-06-24
• Results First Posted: 2023-07-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 110

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified