Fifty patients (25 per group) with the signs and symptoms of
allergic conjunctivitis confirmed by positive skin test enrolled in this randomized, double-blind, parallel group, 2-week comparison of
pentigetide, 0.5%,
ophthalmic solution (
Pentyde) and
cromolyn sodium, 4%, USP
ophthalmic solution (
Opticrom). The physician and the patient rated the patient's overall ocular condition on days 3, 8, and 15. On day 15 both the physician and the patients rated the
pentigetide group as significantly (Chi-square, P less than .05) more improved than the
cromolyn sodium group. The physician rated independently conjunctival symptoms and ocular signs at days 1, 3, 8, and 15. Improvement in signs and symptoms favored
pentigetide in the majority of comparisons to
cromolyn sodium (14 of 18). The
pentigetide group showed significantly (ANOVA, P less than .05) greater improvement in
hyperemia,
edema, lacrimation, and blurred vision/
photophobia. Patients completed daily diaries for seven symptoms. At the end of the study, comparisons to baseline between groups favored the
pentigetide group for six of the seven symptoms; for
itching, improvement favored significantly (ANOVA, P less than .05) the
pentigetide group. The mean severity of all symptoms decreased by 64% in the
pentigetide group as compared with a decrease of 46% in the
cromolyn sodium group. Adverse experiences were minor and comparable in both groups. No clinically abnormal changes were noted for visual acuity, intraocular pressure, or common laboratory tests. This double-blind, active-controlled trial demonstrates that
pentigetide, 0.5%,
ophthalmic solution is safe and effective in the treatment of
allergic conjunctivitis.