Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings

Autor: Paul L. Kaufman, Jeffrey M. Liebmann, Robert N. Weinreb, Keith R Martin, Jason L Vittitow
Rok vydání: 2018
Předmět:
Male
Aging
Intraocular pressure
genetic structures
Visual Acuity
Phases of clinical research
Ocular hypertension
Glaucoma
Neurodegenerative
Ophthalmology & Optometry
Original Studies
law.invention
0302 clinical medicine
Randomized controlled trial
law
80 and over
latanoprostene bunod
Medicine
nitric oxide donor
Aged
80 and over

Cross-Over Studies
Middle Aged
prostaglandin analog
Latanoprostene Bunod
Open-Angle
6.1 Pharmaceuticals
Prostaglandins F
Synthetic

Timolol
Female
Patient Safety
Glaucoma
Open-Angle

Adult
safety
medicine.medical_specialty
Open angle glaucoma
Clinical Trials and Supportive Activities
Clinical Sciences
open-angle glaucoma
and over
Tonometry
Tonometry
Ocular

Young Adult
03 medical and health sciences
intraocular pressure
Double-Blind Method
Clinical Research
Ocular
Ophthalmology
Humans
diurnal
Eye Disease and Disorders of Vision
Antihypertensive Agents
Intraocular Pressure
Aged
business.industry
Prostaglandins F
Synthetic
Neurosciences
Evaluation of treatments and therapeutic interventions
medicine.disease
Crossover study
eye diseases
030221 ophthalmology & optometry
ocular hypertension
Ocular Hypertension
sense organs
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Zdroj: Journal of glaucoma, vol 27, iss 1
J Glaucoma
ISSN: 1057-0829
Popis: PURPOSE:To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). PATIENTS AND METHODS:Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12. RESULTS:Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P
Databáze: OpenAIRE