title: Effectiveness and safety of 0.15% ganciclovir in situ ophthalmic gel for herpes simplex keratitis - a multicenter, randomized, investigator-masked, parallel group study in Chinese patients.
abstract: OBJECTIVE
  Parallel comparison with 0.15% ganciclovir (GCV) ophthalmic gel to evaluate the effectiveness and safety of 0.15% GCV in situ ophthalmic gel for the treatment of herpes simplex keratitis (HSK).
  
  
  METHODS
  This was a multicenter, randomized, investigator-masked, parallel group study. HSK patients were randomly divided into two groups, with the corresponding treatment of 0.15% GCV ophthalmic gel or 0.15% GCV in situ ophthalmic gel. Symptoms and signs were observed before administration, and 3 (±1), 7 (±1), 14 (±2), and 21 (±3) days after the administration. The clinical effective rate was considered as the primary outcome. The safety profile was evaluated by AEs, visual acuity, and ocular tolerance.
  
  
  RESULTS
  The clinical effective rate in the per-protocol (PP) dataset for the treatment group and the control group were 95.10% and 93.00%, respectively (P = 0.5282). The noninferiority test showed significant differences (P = 0.000305, P < 0.025), indicating that the tested drug was noninferior to the control. Patients in the PP dataset of both groups experienced decreases in the total scores of clinical indicators. Ocular AEs were few but similar between the two groups. There were no significant differences between patients' visions between the two groups before and after administration in the safety analysis set. In terms of drug tolerance, the rates of patients without transient blurred vision during all the visits in the treatment group were higher than those for the control group (P < 0.05). During the third and fourth visits, the rates of patients with eye itching were 4.08% and 1.22% in the treatment group, and 13.59% and 8.14% in the control group, respectively (P < 0.05). During the second visit, the rates of patients with eye irritation were 14.42% in the treatment group and 25.71% in the control group (P < 0.05).
  
  
  CONCLUSIONS
  The 0.15% GCV in situ ophthalmic gel was effective and safe for the treatment of HSK, and was not inferior to 0.15% GCV ophthalmic gel. The 0.15% GCV in situ ophthalmic gel presented superior ocular tolerance.
authors.affiliation: Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, People's Republic of China.
authors.forename: Tong
authors.initials: T
authors.lastname: Lin
authors.forename: Lan
authors.initials: L
authors.lastname: Gong
authors.forename: Xing-Huai
authors.initials: XH
authors.lastname: Sun
authors.forename: Nai-Qing
authors.initials: NQ
authors.lastname: Zhao
authors.forename: Wei
authors.initials: W
authors.lastname: Chen
authors.forename: Hui-Ping
authors.initials: HP
authors.lastname: Yuan
authors.forename: Yan
authors.initials: Y
authors.lastname: Shao
authors.forename: Ming-Hong
authors.initials: MH
authors.lastname: Gao
authors.forename: Hai
authors.initials: H
authors.lastname: Tang
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D005782:Gels; D006801:Humans; D016849:Keratitis, Herpetic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method
chemical_list: D000998:Antiviral Agents; D005782:Gels; D015774:Ganciclovir
keywords: ganciclovir in situ ophthalmic gel; herpes simplex virus 1; treatment; virus keratitis