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A study of the efficacy and treatment adherence of preservative-free tafluprost based on an electronic patient reporting system

A study of the efficacy and treatment adherence of preservative-free tafluprost based on an electronic patient reporting system

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101796
Enrollment
Unknown
Registered
2025-04-29
Start date
2023-02-13
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

glaucoma

Interventions

PF-TPR group:Use preservative-free tafluprost eye drops
control group:Continue to use their original IOP-lowering eye drops that contain preservatives

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients (= 18 year-old) with primary open-angle glaucoma (POAG) or ocular hypertension (OHT); (2) under treatment using a single preservative-containing IOP-lowering eye drop at least 3 months; (3) baseline IOP (under medication) <= 25 mmHg with a stable visual field over the past 6 months.

Exclusion criteria

Exclusion criteria: (1) current IOP-lowering treatment with fixed-dose combination or more than one medication; (2) application of artificial tears within or anti-inflammatory eye drops within 4 weeks; (3) severe blepharitis, meibomian gland dysfunction, keratitis, conjunctivitis, uveitis, pterygium, secondary glaucoma, angle closure glaucoma, diabetes, current pregnancy, breastfeeding, history of intraocular surgeries, refractive surgery, or ocular trauma within 1 year.

Design outcomes

Primary

MeasureTime frame
the changes in OSDI score from baseline at week 12;the tear meniscus height (TMH);bulbar redness;noninvasive tear breakup time (NITBUT);tear film layer thickness (TFLT) ;the changes in C-GTCAT score from baseline at week 12;the changes in C-GTCAT score from baseline at week 4;

Secondary

MeasureTime frame
the changes in OSDI score from baseline at week 4;non-inferiority efficacy of PF-TPR in lowering IOP;

Countries

China

Contacts

Public ContactDuan Xuanchu

Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital

duanxchu@csu.edu.cn+86 138 0731 4691

Outcome results

None listed

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