Purpose: To evaluate the impact of age, glaucoma-specific diagnosis, and history of prior glaucoma surgery on outcomes in pediatric patients treated with latanoprost monotherapy.
Patients and Methods: Prospective, randomized, double-masked 12-week, multicenter study included individuals 18 years or younger with glaucoma. Subjects stratified by age (0 to <3, 3 to <12, 12 to 18 y), diagnosis [primary congenital glaucoma (PCG) vs. non-PCG], and baseline intraocular pressure (IOP; 22 to <27, 27 to 31, >31 mm Hg), and randomized (1:1) to latanoprost vehicle (8 AM) and latanoprost 0.005% (8 PM) or timolol 0.5% (or 0.25% for those less than 3 y old; 8 AM/8 PM). IOP and safety assessments performed and adverse events recorded at baseline, weeks 1, 4, 12. Post hoc analyses in age-specific and diagnosis-specific groups of latanoprost-treated subjects were conducted (intent-to-treat population).
Results: Sixty-eight subjects were treated with latanoprost (0 to <3, n=17; 3 to <12, n=26; 12 to 18, n=25); 82%, 42%, and 24%, respectively, had a primary diagnosis of PCG. Among Non-PCG subjects, 0% (0/3), 47% (7/15), and 63% (12/19) had a primary diagnosis of juvenile open-angle glaucoma in the 0 to <3, 3 to <12, and 12 to 18 year cohorts, respectively. Mean percent IOP reductions from baseline at week 12 were 22%, 24%, and 30% in the youngest through oldest age groups, respectively (P=0.3600). At week 12, a higher responder rate (≥15% IOP reduction) was observed in the non-PCG than in the PCG group (70% vs. 45%, respectively; P=0.0361). Latanoprost was well tolerated.
Conclusion: All age and diagnosis subgroups showed clinically relevant (>20%) mean IOP reduction at week 12 with latanoprost monotherapy.
*Pfizer Inc., New London, CT
†Pfizer Inc., La Jolla, CA
‡Private Practice, Jupiter, FL
§Pediatric Ophthalmology Department, University Hospital of Amiens, INSERM UMRS 968, France
∥Duke Eye Center, Durham, NC
¶NIHR Biomedical Research Centre, Moorfields Eye Hospital & UCL Institute of Ophthalmology, London, United Kingdom
#Moran Eye Center, University of Utah, Salt Lake City, UT
Supported by Pfizer Inc., New York, NY.
Disclosure: P.T.K. was funded by the NIHR Biomedical Research Centre in Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology. E.Y. is an employee of Pfizer Inc. T.M.-C., K.C-B and B.W. were employees of Pfizer Inc. at the time the study was conducted and the manuscript developed. B.S., S.F. are currently consultants for Pfizer Inc. P.T.K. is currently a consultant for Pfizer Inc., Alcon, Allergan, Bausch & Lomb, and AstraZeneca. The remaining authors declares no conflicts of interest.
Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website, www.glaucomajournal.com.
Reprints: Tomoko Maeda-Chubachi, MD, PhD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 (e-mail: email@example.com).
Received July 8, 2011
Accepted January 9, 2012