Efficacy and safety of artificial tears containing Artemia salina extract with dinucleotides for dry eye

ABSTRACT

Clinical relevance

This clinical trial was conducted as part of the marketing procedures for a medical device comprising artificial tears containing Artemia salina extract with dinucleotides. These molecules previously demonstrated secretagogue properties by enhancing the production of aqueous, mucinous, and lipidic components of the tears.

Background

After confirming the efficacy of artificial tears containing Artemia salina extract in an animal model, this study proceeded to evaluate their efficacy and safety on dry eye participants.

Methods

A randomised controlled clinical trial was performed on 36 dry eye participants (41.6 ± 20.6 years). Half of the participants were treated with saline solution as a placebo for four weeks, while the other half were treated with artificial tears containing Artemia salina, randomly assigned. After a wash-out period of two weeks, the treatments were crossed for another four weeks. Participants were assessed at baseline and after one week, two weeks, and four weeks. Efficacy variables were: eye dryness frequency (primary), eye comfort, visual satisfaction, tear secretion, tear break-up time, corneal staining, conjunctival staining, and conjunctival hyperaemia. Safety variables were: high- and low-contrast visual acuity, intraocular pressure, and eye fundus images analysis.

Results

Compared with the baseline, the saline solution showed no significant changes in any of the studied variables after four weeks of treatment (p ≥ 0.05). However, the topical instillation of the artificial tears with Artemia salina for four weeks significantly improved eye dryness frequency (p = 0.014) and corneal staining (p = 0.010). No systemic or ocular adverse events were reported during the clinical trial.

Conclusion

The topical instillation of artificial tears containing Artemia salina in mild to moderate dry eye participants for four weeks slightly improved their symptoms related to eye dryness frequency and reduced corneal damage, with no undesirable side effects observed.

KEYWORDS:

• Artemia salina
• artificial tears
• dinucleotides
• dry eye
• purinergic signalling

Acknowledgements

This study was published in memory of Jesus Pintor, who passed away on 2 April 2019. He founded and led our research group working continuously on the relationship between purinergic signaling and dry eye.

Disclosure statement

Gonzalo Carracedo has a patent for the preparation and use of an extract of Artemia salina to treat the ocular surface (WO/2018/015582). The remaining authors have no financial or proprietary interest in any material or method mentioned. This study was privately funded by Avizor (Madrid, Spain).