Prostaglandin F2 alpha-isopropylester eye drops: effects in normal human eyes.

The effects of PGF2 alpha-isopropylester eye drops on intraocular pressure (IOP) and aqueous humour dynamics were investigated in healthy male volunteers. The other eye was treated with vehicle and used as a control. Special attention was also paid to adverse effects. Single and repeated doses were tested. There was a dose related effect on IOP. Significant reductions were observed 4, 8, and 12 hours after application of 1.0, 2.5, or 10 micrograms PGF2 alpha equivalents of the drug. With 10 micrograms the effect lasted 24 hours. An initial tendency towards an increase in IOP was observed for these doses. Repeated doses of 1.0 microgram daily or 0.5 microgram twice daily produced a significant and lasting IOP reduction of about 2 mmHg for 1-2 weeks. Aqueous humour production was not altered, and outflow facility was not significantly changed. There was a dose dependent hyperaemia with a maximum within 2 hours after application. A foreign body sensation, some pain, and photophobia were noted with increasing doses. A slight miosis of 1 mm was seen in three of six eyes treated with 10 micrograms. No signs of intraocular inflammation were recorded, but a slight increase in penetration of fluorescein into the anterior chamber was observed after 16 days of treatment.

RCT Entities:   Population Interventions Outcomes