Comparison of dorzolamide and pilocarpine as adjunctive therapy in patients with open-angle glaucoma and ocular hypertension.

Many patients with glaucoma or ocular hypertension initially receive beta-blocker monotherapy to control intraocular pressure (IOP), but some of these patients will require an additional IOP-lowering agent within 1 year. This active-controlled, double-masked, randomized, multicenter, 12-week study compared the effectiveness and tolerability of dorzolamide hydrochloride ophthalmic solution 2% TID with those of pilocarpine hydrochloride 2% QID as adjunctive therapy to timolol maleate ophthalmic gel-forming solution (TG) 0.5% QD as measured by changes in IOP and occurrence of adverse events. One hundred ninety-four patients with open-angle glaucoma or ocular hypertension participated in this study. Their mean age was approximately 63 years. Slightly more than one half were white, and approximately one third were black. After a 3-week run-in period during which all patients received TG 0.5% QD, patients with an IOP of > or = 22 mm Hg at the morning trough measurement were randomly assigned to receive additional double-masked therapy with either dorzolamide or pilocarpine. The primary outcome measure was the mean change in IOP at the morning trough measurement from baseline to week 12. The secondary outcome measure was the mean change in IOP at the morning peak measurement from baseline to week 12. There was no significant difference in IOP-lowering effect between the 2 drugs at either morning trough or morning peak. The mean change in IOP at morning trough was -3.17 mm Hg (-12%) in patients receiving dorzolamide; it was -3.45 mm Hg (-13%) in patients receiving pilocarpine. The mean change in IOP at morning peak was -2.25 mm Hg (-10%) for patients who received dorzolamide and -2.51 mm Hg (-11%) for those who received pilocarpine. In the pilocarpine group, 62 (63%) patients experienced > or =1 adverse event compared with 35 (36%) patients in the dorzolamide group (P < 0.001). Twenty-one (21%) patients in the pilocarpine group discontinued treatment because of an adverse event compared with 2 (2%) patients in the dorzolamide group (P < 0.001). These results demonstrate that dorzolamide and pilocarpine were equally effective as adjunctive therapy in lowering IOP but that dorzolamide was better tolerated.

The effectiveness and safety of dorzolamide 2% in addition to multiple topical antiglaucoma medications.

Dorzolamide is the first commercial topical carbonic anhydrase inhibitor approved by the Food and Drug Administration (FDA) for the treatment of glaucoma. In a prospective, open label, uncontrolled study on 245 glaucoma patients, dorzolamide significantly lowered the intraocular pressure at least 14% when used alone or in combination with one, two, or three other antiglaucoma medications over ten weeks. There were very few adverse reactions to dorzolamide. Dorzolamide is effective and safe when used alone or in combination with other topical antiglaucoma medications for the treatment of glaucoma.

A randomized study of dorzolamide in the prevention of elevated intraocular pressure after anterior segment laser surgery. Dorzolamide Laser Study Group.

PURPOSE: To evaluate the efficacy of 2% dorzolamide hydrochloride opthalmic solution in preventing spikes in intraocular pressure (IOP) after anterior segment laser surgery. METHODS: This 24-hour, placebo-controlled, randomized, double-masked, multicenter evaluation was conducted to determine the efficacy of dorzolamide hydrochloride 2% in controlling IOP after neodimium:yttrium-aluminum-garnet (Nd:YAG) laser capsulotomy, argon laser trabeculoplasty, or laser iridotomy. The 122 patients enrolled were assigned in randomized fashion to receive dorzolamide or placebo 1 hour before and immediately after the procedure; IOP was measured 1, 2, 3, 4, and 24 hours after the procedure. RESULTS: Of 61 patients receiving dorzolamide, only one (1.7%) had a spike in IOP of 10 mmHg or more, compared with 9 (14.8%) of the 61 patients receiving placebo. Mean IOP among patients receiving dorzolamide was significantly reduced both from baseline and compared with that among patients receiving placebo from 1 to 4 hours after administration. Only 5 (8%) of the 61 patients receiving dorzolamide experienced at least one adverse event, compared with 15 (25%) of the 61 patients receiving placebo. CONCLUSION: Dorzolamide was effective in preventing spikes in IOP after anterior segment laser surgery. Dorzolamide was generally well tolerated after short-term use.

Patient preference, efficacy, and compliance with timolol maleate ophthalmic gel-forming solution versus timolol maleate ophthalmic solution in patients with ocular hypertension or open-angle glaucoma.

This study was designed to compare timolol maleate ophthalmic gel-forming solution 0.5% (timolol gel) once daily with timolol maleate ophthalmic solution 0.5% (timolol solution) twice daily with respect to patient preference, intraocular pressure (IOP)-lowering effect, and tolerability. A total of 202 patients with ocular hypertension or open-angle glaucoma and an IOP > or = 22 mm Hg were enrolled in this 12-week, randomized, observer-masked, two-period crossover study. Significantly more patients preferred timolol gel to timolol solution (P < 0.001). Ninety-two percent of patients preferring timolol gel strongly agreed or agreed that once-daily dosing was a reason for their preference. Those who preferred timolol solution did so because of fewer side effects. The mean IOP-lowering effects of the 2 treatments were similar at both morning trough and peak time points. The incidence of drug-related adverse experiences was similar (timolol gel 11.4% vs timolol solution 10.9%). Because both treatments were well tolerated and effective in lowering IOP, timolol gel, with its once-daily dosing regimen, should be considered in patients who are candidates for therapy with an ophthalmic beta-blocking agent.

Efficacy and tolerability of 0.5% timolol maleate ophthalmic gel-forming solution QD compared with 0.5% levobunolol hydrochloride BID in patients with open-angle glaucoma or ocular hypertension.

We compared the efficacy of timolol maleate ophthalmic gel-forming solution 0.5% QD with that of levobunolol hydrochloride 0.5% BID, as measured by change in intraocular pressure (IOP), effect on heart rate, and ocular tolerability. The study had a positive-controlled, double-masked, randomized, multicenter, 12-week, two-period (6 weeks each), crossover design. One hundred fifty-two patients with open-angle glaucoma or ocular hypertension were randomized to receive either timolol maleate gel-forming solution QD or levobunolol BID for 6 weeks, followed by a crossover to the alternate treatment. IOP and heart rate were measured at morning trough and peak during weeks 3, 6, 9, and 12. Timolol maleate gel-forming solution QD was comparable to levobunolol BID in reducing IOP at peak and trough. Although the effects on peak heart rate were similar between the two medications, the effect on trough heart rate of timolol maleate gel-forming solution QD was significantly less than that of levobunolol BID (P = 0.001). The incidence of ocular burning and stinging was comparable between the two treatments. Patients experienced significantly more blurred vision when using timolol maleate gel-forming solution than when using levobunolol (P = 0.013). Overall, more patients experienced at least one adverse event when using timolol maleate gel-forming solution. Timolol maleate gel-forming solution QD is as efficacious in reducing IOP as levobunolol BID.

The efficacy of dorzolamide, a topical carbonic anhydrase inhibitor, in combination with timolol in the treatment of patients with open-angle glaucoma and ocular hypertension.

The effectiveness of dorzolamide 2%, a topical carbonic anhydrase inhibitor, administered three times daily (TID) concomitantly with timolol 0.5% given twice daily (BID) was evaluated in one arm of a large, 1-year, multicenter efficacy and safety trial. That study compared dorzolamide 2% TID with betaxolol 0.5% BID and timolol 0.5% BID as monotherapy in patients with open-angle glaucoma or ocular hypertension. Ninety-seven patients with uncontrolled intraocular pressure (IOP) (ie, greater than 21 mm Hg) or with a reduction in IOP of less than 15% from baseline during monotherapy with dorzolamide required 0.5% timolol BID as adjunctive therapy; 95 patients were evaluated for efficacy. IOP was measured 1 week after starting adjunctive therapy and at all subsequent study visits. Data were evaluated as change in IOP from original baseline and change in IOP from end of monotherapy treatment. A clinically meaningful additive effect on IOP was observed at all time points. After 1 week of adjunctive therapy, the mean percent reduction from baseline in peak and afternoon trough IOPs was 34% and 28%, respectively. These results demonstrate that dorzolamide and timolol have an additive effect in lowering IOP. This combination was generally well tolerated by the patients in this study.