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.
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Reprints: Tomoko Maeda-Chubachi, MD, PhD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 (e-mail: firstname.lastname@example.org).
Received July 8, 2011
Accepted January 9, 2012