Effectiveness and safety of tafluprost 0.0015% mono-therapy in Chinese patients with primary open-angle glaucoma and ocular hypertension

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-17011980

Enrollment

Unknown

Registered

2017-07-13

Start date

2017-12-27

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary open-angle glaucoma and ocular hypertension

Interventions

Treat group:Treated with one drop of tafluprost 0.0015% Ophthalmic Solution in the affected eye(s) in the evening once daily

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chinese males or females, =18 years old; 2. Diagnosed with open-angle glaucoma or ocular hypertension, who were either previously untreated or inadequately responsive to other IOP-lowering monotherapy; 3. Patients who are willing to complete the visits and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled systemic disease or active non-glaucoma ocular disease; 2. Known hypersensitivity or contraindications to any components of the study medications; 3. Any corneal lesions precluding accurate tonometry reading; 4. Participation in other drug or devices trials within 30 days before the enrollment; 5. Having pregnancy planned or being pregnant or nursing; 6. IOP=35mmHg in either eye for treatment na?ve patients, and IOP>28mmHg or IOP<17mmHg for pre-treated patients; 7. Treated with anti-glaucoma mixture or combination therapy in the past 1 month; 8. Previous intraocular surgery in the past 3 months; 9. Other conditions based on physicians judgments.

Design outcomes

Primary

Measure	Time frame
Mean IOP change at month 3 in each subgroup (3 subgroups: previously untreated patients, group A; patients switched from other PGA, group B; patients switched from non-PG, group C);	—

Secondary

Measure	Time frame
Mean IOP change at week 1& month 1 in each subgroup;Percentage of IOP reduction at week 1, month 1 and month 3 in each subgroup;The proportion of patients with IOP reduction=20% & =30% in group A at week 1, month 1 and month 3;The proportion of patients with further IOP reduction = 1mmHg in group B & C at month 1 and month 3;	—

Countries

China

Contacts

Public ContactWei Wang

Santen Pharmaceutical (China) Co., Ltd.

weiwang02@santen-china.cn+86 15210821977

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026