glaucoma
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| the changes in OSDI score from baseline at week 4;non-inferiority efficacy of PF-TPR in lowering IOP; | — |
Countries
China
Contacts
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital