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Sota Watanabe, Hiroshi Toshida, Nobuhito Tabuchi, Toshinari Funaki, Koichi Ono, Tamotsu Seki, Hiroshi Otake, Takuji Kato, Nobuyuki Ebihara, Akira Murakami; Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2704. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye.
In total, 66 patients (6 males and 60 females; mean age, 49.0 ± 18.0 years) with dry eye participated in this study, following approval from Institutional Review Board; informed consent was obtained from all the patients. After a 2-week wash-out period with artificial tears, patients were randomized (1:1) to either a VApal ophthalmic solution (500 IU/mL) group or placebo group and were administered a single drop of either of these six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms (dryness, eye fatigue, foreign body sensation, blurred vision, eye pain, photophobia, heaviness, itching, ocular discomfort, eye discharge, tearing, and hyperemia), fluorescein (F) staining score, Rose Bengal (RB) staining score, tear film break-up time (BUT), and tear secretion with Schirmer’s test I. Safety measures included clinical blood and urine examinations and adverse event recordings.
On comparing the two groups, the clearing rate of F staining score was found to be significantly higher in the VApal group than in the placebo group at 4 weeks (p < 0.05). The mean change in the RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (p < 0.05 and p < 0.01, respectively). Of the 12 subjective symptoms, blurred vision significantly improved in the VApal group compared with that in the placebo group at 1 and 2 weeks (p < 0.01 and p < 0.05, respectively), and the mean change in the total score of subjective symptoms from baseline was significantly lower in the VApal group at 1 week (p < 0.05). In the before and after intervention comparison between the two groups, the F staining and RB staining scores showed improvement in both groups. Improvement was noted for 11 subjective symptoms in the VApal group, whereas it was noted for 7 in the placebo group. Adverse events (adverse reactions) occurred in three (zero) patients from the VApal group and in two (one) patients from the placebo group; no significant difference was observed between the two groups.
The VApal ophthalmic solution (500 IU/mL) is effective and safe for the treatment of patients with dry eye.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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