A double-blind randomized clinical study was conducted to determine whether
nicardipine hydrochloride was a useful treatment for dry eye. We examined
its effect on the tear film, ocular surface and ocular comfort. Nicardipine
hydrochloride, 3-isobutyl-1-methylxanthine and pilocarpine hydrochloride w
ere dissolved in an artificial tear vehicle and applied topically to one ey
e of 12 subjects on separate days. Ocular physiology, ocular comfort and te
ar volume were assessed. The trial was repeated with nicardipine in an aque
ous gel vehicle. Tears were collected and assessed for protein concentratio
n and protein profile, using electrophoresis and mass spectrometry. Nicardi
pine induced conjunctival redness and symptoms of dryness and irritation. T
here was no change in total tear protein concentration or volume. An increa
se in a 68 kDa protein was observed, this was probably due to conjunctival
vessel dilation and leakage of albumin. The adverse symptomatology and incr
eased conjunctival redness experienced with nicardipine make it an undesira
ble treatment for dry eye.