Ophthalmic Solution Safety Profile: Active Surveillance of a Sodium Hyaluronate/Chondroitin Sulfate Combination in Peruvian Population

Abstract

Background

Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)’ real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population.

Methods

Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM).

Results

Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups.

Conclusion

Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM’s physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM’s safety profile.

Keywords:

• post-marketing surveillance
• adverse drug reaction
• artificial tears
• dry eye disease

Data Sharing Statement

The data presented in this study are available on request from the corresponding author.

Ethics Approval

This study was approved by the “Comité Institucional de Bioética (CIB), Vía libre”, located in Lima, Perú (Approval Number 4205, Dic-18-2018). This study was conducted in compliance with international guidelines and in accordance with strictest international ethical regulations for research.

Acknowledgments

This study was sponsored by Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). The sponsor provided support in the form of salaries for authors (HCS, MBH, LMBD, VOC and LYRH), but did not have any additional role in the data collection. The authors thank Alejandra Sánchez Rios, MD for the medical writing support.

Disclosure

Homero Contreras-Salinas, Mariana Barajas-Hernández, Leopoldo Martín Baiza-Durán, Vanessa Orozco-Ceja, Lourdes Yolotzin Rodríguez-Herrera are employees of Laboratorios Sophia S.A. de C.V. The authors report no other conflicts of interest.