June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye
Author Affiliations & Notes
  • Sota Watanabe
    Pharmaceutical Research Laboratories No.1, Research & Development Headquarters, Lion Corporation, Kanagawa, Japan
  • Hiroshi Toshida
    Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka, Japan
  • Nobuhito Tabuchi
    Pharmaceutical Research Laboratories No.1, Research & Development Headquarters, Lion Corporation, Kanagawa, Japan
  • Toshinari Funaki
    Department of Ophthalmology, Juntendo University Graduate School of Medicine, Tokyo, Japan
  • Koichi Ono
    Department of Ophthalmology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan
  • Tamotsu Seki
    Tamagawa Eye Clinic, Tokyo, Japan
  • Hiroshi Otake
    Otake Eye Clinic, Kanagawa, Japan
  • Takuji Kato
    Kato Eye Clinic, Tokyo, Japan
  • Nobuyuki Ebihara
    Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan
  • Akira Murakami
    Department of Ophthalmology, Juntendo University Graduate School of Medicine, Tokyo, Japan
  • Footnotes
    Commercial Relationships   Sota Watanabe, Lion Corporation (E), Lion Corporation (P); Hiroshi Toshida, None; Nobuhito Tabuchi, Lion Corporation (E), Lion Corporation (P); Toshinari Funaki, None; Koichi Ono, None; Tamotsu Seki, None; Hiroshi Otake, None; Takuji Kato, None; Nobuyuki Ebihara, None; Akira Murakami, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2704. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      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.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : 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.

Methods : 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.

Results : 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.

Conclusions : 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.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×