Safety of unoprostone isopropyl 0.15% ophthalmic solution in patients with mild to moderate asthma.
OBJECTIVE
To assess the safety of unoprostone isopropyl 0.15% ophthalmic solution (UIOS) in patients with mild to moderate asthma.


METHODS
Randomized, double-masked, two-period crossover, placebo-controlled study comparing unoprostone 0.15% with vehicle-placebo. Pulmonary function tests conducted at baseline and during the 4-hour postdose observation period included forced expiratory volume in 1 s, forced vital capacity, peak expiratory flow rate, and bronchodilator response after 200 microg inhaled salbutamol.


RESULTS
There were no significant changes in pulmonary function up to 4 h postdose after treatment with 1 drop unoprostone 0.15% in each eye.


CONCLUSIONS
Unoprostone 0.15% was safe for use in patients with mild to moderate asthma, without affecting the response to bronchodilator therapy.
Gunawardena
Kulasiri A
KA
Novartis Ophthalmics AG, Bülach, Switzerland.
Crame
Nathan
N
Mertz
Beat
B
Shams
Naveed
N
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000627:therapeutic use; D018592:Cross-Over Studies; D015237:Dinoprost / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D012129:Respiratory Function Tests; D012449:Safety; D013147:Spirometry; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001993:Bronchodilator Agents; D009883:Ophthalmic Solutions; C072630:isopropyl unoprostone; D015237:Dinoprost