COMPARISON OF APRACLONIDINE AND TIMOLOL IN CHRONIC OPEN-ANGLE GLAUCOMA - A 3-MONTH STUDY

Purpose: To compare the safety and efficacy of apraclonidine ophthalmi c solution 0.25% and 0.5% (both given 3 times daily) to timolol maleat e (0.5%) given twice daily, in primary open-angle glaucoma or ocular h ypertension. Methods: This study was a 90-day prospective, multicenter , double-masked, randomized, parallel group trial. Intraocular pressur e (IOP) measurements were made between 8:00 and 10:00 AM before the mo rning dose (i.e., up to 12 hours after the evening dose of glaucoma me dication) and at 4:00 PM (i.e., 8 hours after the morning dose of glau coma medication). Patients with off-therapy IOP of greater than 22 mmH g and less than 35 mmHg were entered into the study and were assessed 14, 30, and 90 days after treatment. Results: Sixty-nine patients were enrolled; there were no significant demographic differences among the three study groups. All three treatments significantly reduced IOP ov er 90 days (P < 0.011). For apraclonidine 0.5%, IOP reductions from 25 .8 +/- 3.2 mmHg (pretreatment) to 20.4 +/- 4.00 mmHg (day 90) were obs erved; for apraclonidine 0.25%, from 25.7 +/- 3.05 mmHg (pretreatment) to 22.1 +/- 4.24 mmHg (day 90); and for timolol 0.5% from 26.1 +/- 3. 79 mmHg to 21.1 +/- 5.91 mmHg (day 90). The 90-day period of therapy w as completed by 12 patients treated with apraclonidine 0.5%, 21 patien ts treated with apraclonidine 0.25%, and 23 patients treated with timo lol 0.5%. There were no serious adverse events. Fourteen of 22 patient s (0.5% apraclonidine) and 21 of 23 patients (0.25% apraclonidine) tol erated the drug well; ocular allergy developed in the remaining patien ts treated with apraclonidine, which resolved upon discontinuation. Co nclusions: Apraclonidine effectively lowers IOP associated with open-a ngle glaucoma or ocular hypertension; these pilot results will need to be confirmed by a larger pivotal study. Long-term therapy for some pa tients may be inhibited by ocular allergy for which there was a higher incidence to the 0.5% apraclonidine solution than to the 0.25% soluti on in this study. Apraclonidine may be of value as an additional thera py for open-angle glaucoma in selected patients.