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Editors Selection IGR 19-1
Medical Treatment: Travoprost vs. Timolol in Pediatric Glaucoma
Comment by Stefano Miglior on:
74332 A 3-month safety and efficacy study of travoprost 0.004% ophthalmic solution compared with timolol in pediatric patients with glaucoma or ocular hypertension, Dixon ER; Landry T; Venkataraman S et al., Journal of AAPOS, 2017; 21: 370-374.e1
Management of pediatric glaucoma is particularly challenging and, despite being primarily surgical, medical treatment is widely used and significant. However, medical therapy is limited due to the possibility of systemic adverse events and to the lack of robust scientific evidence concerning both safety and efficacy.
In this paper the authors report the results of a double masked, randomized, prospectictively planned clinical trial comparing travoprost 0.004% with timolol 0.25% or 0.5% (depending on the agegroups) in pediatric patients with glaucoma or ocular hypertension.
The study is well executed clinically, considering the high degree of difficulty associated with acquiring accurate IOP measurements (which may require the need of sedation or anesthesia) in infants and young children. The only major concern is the single day wash out from previous medications, which likely affected accurate baseline IOP measurements. While some children were without therapy, a higher number were on medical treatment including beta-blockers, PG analogues and carbonic anhydrase inhibitors, and in some cases two medications. A minor concern is the 3 month follow up period which is insufficient to allow long-term evaluation of the study drugs.
The results show that travoprost 0.004% and timolol had no statistically significant differences (non inferiority) at the 3 month time point both in terms of efficacy (about 5-6 mmHg reduction from baseline, either in the Intention to Treat or in the Per Protocol analyses) and in terms of safety (with no relevant side effects or systemic events closely related to the studied drugs).
The results of this study represent the first data on safety and efficacy of a PG analogue (namely travoprost 0.004%) from a double blind prospectively planned randomized clinical trial in pediatric patientsThe results of this study represent the first data on safety and efficacy of a PG analogue (namely travoprost 0.004%) from a double blind prospectively planned randomized clinical trial in pediatric patients. Their impact on daily practice is scientifically and clinically relevant, and should help clinicians in better manage pediatric glaucoma.
