Efficacy and safety of a soft contact lens to control myopia progression.

CLINICAL RELEVANCE: The control of myopia progression is currently considered an evidence-based therapeutic need. BACKGROUND: To determine the efficacy and safety of the Esencia lens, a new soft contact lens (SCL) designed to slow down myopia progression in paediatric patients. METHODS: This study was a randomised, parallel, double-masked clinical trial. Seventy myopic (-0.50 to -8.75 D) boys and girls, 7-15-years of age, were randomised and allocated to one of two groups: (i) study (n = 36) or (ii) control (n = 34). Study group patients were given the Esencia lens, a progressive multifocal and reverse geometry SCL. Control group patients were given conventional SCLs. Efficacy measurements (change in cycloplegic autorefraction and axial length) were measured at baseline and at the six-month intervals over a 12- month period. Visual performance measurements were corneal power, comfort, quality of vision and contact lens fitting. Safety measures included detection of adverse events. RESULTS: Mean changes in cycloplegic autorefraction after 12-months were -0.28 ± 0.35 D for study and -0.57 ± 0.52 D for control group patients (p = 0.02). A significantly lower increase in axial length was found in the study group (0.13 ± 0.12-mm) compared to control (0.22 ± 0.14-mm) patients (p = 0.03). Compared to control group patients, there was less myopia progression in the study group: 51 and 41 per cent in terms of cycloplegic autorefraction and axial length, respectively. No significant differences between groups for change in corneal power, comfort, vision quality and contact lens fitting were found (p > 0.05). Regarding safety, there were no serious and/or unexpected adverse events during the study. CONCLUSIONS: The Esencia lens seems to be efficacious in slowing down progression of myopia in children compared to traditional SCLs in the short term, with comparable safety features and visual outcomes.

Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs).

BACKGROUND: Compliance aids are devices which have been developed and are currently used to assist individuals in their medicines management. The use of compliance aids involves the transfer of medicines from the manufacturers' original packaging and repackaged into an multicompartment compliance aid (MCA). MCAs do not guarantee the same level of protection compared to manufacturer's original packaging. OBJECTIVE: The aim of this study was to investigate the stability profile of atenolol, aspirin and lansoprazole dosage forms repackaged together in two different commercially available MCAs. METHODS: In a laboratory in the United Kingdom, the physical stability of the formulations repackaged into two commercially available brands of MCAs was evaluated. After 8 weeks of storage (under controlled ambient conditions), changes in the disintegration (tablets only) and dissolution properties (all formulations) were examined in accordance with British Pharmacopoeia (BP) specifications. KEY FINDINGS: Findings from this study confirm that changes in solid-dosage form quality are observed when repackaged into MCAs compared to manufacturers packaging resulting in differences in in-vitro dissolution performance. However, even with these changes, overall product performance was acceptable and within BP specifications. CONCLUSION: There is a need for greater collaboration in this area between manufacturers, hospital and community pharmacists, academics and policymakers to increase the data available on the physical stability and in turn performance of medicines repackaged into MCAs.