0.0015％他氟前列素滴眼液与0.005％拉坦前列素滴眼液治疗原发性开角型青光眼和高眼压症的多中心随机单盲平行对照试验

Objective To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension. Safety was also compared between two groups. Methods This study was conducted from August 2008 to December 2009, at five clinical trial sites in China. Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes. Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group. Intraocular pressure (IOP) measurement by Goldmann applanation tonometer, slit-lamp microscopy, Gonioscopy, Fundascopy, Visual acuity test, Perimetry, Blood pressure and pulse rate, Subjective symptoms were compered between two groups at Week 0, Week 2 and Week 4. For main effectiveness evaluation index adopt the bad effect evaluation, safety evaluation index by Fisher′s exact test probability method. Results The 246 subjects/246 eyes were randomized (Tafluprost group: 122 subjects/122 eyes, Latanoprost group: 124 subjects/124 eyes). Change in the IOP at 17: 00 of Week 2 is (8.8±3.8) mmHg and (8.9±4.4) mmHg (1 mmHg=0.133 kPa) in Tafluprost group and Latanoprost group. Percent change in the IOP at 17: 00 of Week 2 is (33.2±12.8)% and (34.4±14.1)% in Tafluprost group and Latanoprost group. Change in the IOP at 17: 00 at the end of treatment is (9.8±4.0) mmHg and (9.2±4.1) mmHg in Tafluprost group and Latanoprost group. Percent change in the IOP at 17: 00 at the end of treatment is 37.2%±13.4% group and 35.7%±13.0% in Tafluprost and Latanoprost group. In addition, distribution of subjects with percentage decrease of IOP>30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group. The major adverse reactions were conjunctival hyperemia, eye irritation, eye pain and foreign body sensation. The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group. The inter-group difference had no statistical significance. Conclusion Efficacy and safety of Tafluprost ophthalmic solution are no less than Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.(Chin J Ophthalmol, 2015, 51: 95-102) Key words: Glaucoma, open-angle; Ocular hypertension; Prostaglandins F; Prostaglandins F, synthetic; Randomized controlled trial