Ganciclovir ophthalmic gel 0.15% for the treatment of acute herpetic keratitis: background, effectiveness, tolerability, safety, and future applications

Figures & data

Figure 1 Large epithelial dendrite due to Herpes simplex virus.

Table 1 Phase II and III clinical studies

	Study one^Citation14				Study two^Citation14,Citation92			Study three^Citation93				Study four^Citation65
	GCV	GCV	ACV	P-value	GCV	ACV	P-value	GCV	GCV	ACV	P-value	GCV	ACV	P-value
	0.15%	0.05%	3.00%		0.15%	3.00%		0.15%	0.05%	3.00%		0.15%	3.00%
N	23	22	22		18	17		36	35	38		84	80
Recovery at day 14 (%)	19 (82.6)	17 (77.3)	16 (72.7)	ns	15 (83.3)	12 (70.6)	ns	31 (86.1)	28 (80)	27 (71.1)	ns	63 (88.7)	61 (91)	ns
Relapses by day 14 (%)	1 (4.3)	1 (1.45)	3 (13.6)	ns	0	1 (5.9)	ns	0	2 (5.7)	3 (7.9)	ns	–	–
Withdrawals (%)	3 (13)	6 (27.3)	7 (31.8)	ns	2 (11.1)	7 (41.2)	0.06	2 (5.56)	4 (11.4)	7 (21.1)	ns	9 (12.37)	7 (10.5)	ns
Blurred vision	13%	14%	14%	ns	39%	77%	–	–	–	–	–	28.1%–45.7%	50.9%–63.6%	<0.02 (except day 10, P=0.056)
Stinging/burning	17%	23%	45%	ns	16%	50%	0.045	–	–	–	–	9.3%–21.43%	14.3%–26.42%	Day 14, P=0.03
Toxic superficial punctate keratitis	13%	0%	1%	0.01	0%	0%	ns	–	–	–	–	3.7%–7.9%	6.1%–16.98%	Day 10, P=0.03
Time to healing in days (median)	7	7	8	ns	6	7	0.056	6	4	7	ns	7	7	ns

Abbreviations: ACV, acyclovir; GCV, ganciclovir; ns, not significant.

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