Safety Of Dorzolamide Research Articles

Effectiveness and Safety of Dorzolamide – Timolol Alone or Combined with Latanoprost in Open-Angle Glaucoma or Ocular Hypertension

Treatment of glaucoma is aimed at reducing intraocular pressure (IOP) to prevent further damage to the optic nerve. For patients who do not respond to monotherapy, combination treatment may be effective in achieving therapeutic reduction or target IOP. To evaluate the effectiveness and safety of dorzolamide 2% with timolol 0.5% alone or combined with latanoprost in reducing IOP in a real-world setting. A prospective, open-label, multicenter, nonrandomized interventional study was designed. Three hundred fifty patients with primary open-angle glaucoma or ocular hypertension and uncontrolled IOP after latanoprost monotherapy for 4 or more weeks were treated with combination dorzolamide-timolol twice daily added to their existing latanoprost therapy (D/T-Add-On; n = 280) or dorzolamide-timolol twice daily monotherapy (D/T-Switch; n = 70). The primary effectiveness outcome measure was the change in IOP after 6 and 12 weeks of treatment. Of the total population, 313 patients completed this trial (248 D/T-Add-On; 65 D/T-Switch). After 12 weeks, the mean +/- SD IOP decrease was -6.3 +/- 3.6 mm Hg (-28.1%) and -5.8 +/- 4.9 mm Hg (-23.5%) in the D/T-Add-On and D/T-Switch groups, respectively (both p < 0.001). Therapeutic response rates (defined as IOP reduction >20%) after 12 weeks of treatment for the D/T-Add-On and the D/T-Switch groups were 66.4% (186/280) and 52.9% (37/70), respectively. There were 116 predominantly mild, nonserious adverse events attributed to the study drugs, reported by 86 (24.6%) patients. The most frequent adverse events were eye irritation (n = 42; 12.0%) and taste perversion (n = 15; 4.3%). No serious adverse events related to the study medications were reported. In patients with primary open-angle glaucoma or ocular hypertension and elevated IOP while on monotherapy with latanoprost, switching to dorzolamide-timolol or combining dorzolamide-timolol with latanoprost are effective and safe treatment options for reducing IOP and achieving therapeutic response.

Comparison of the Efficacy and Safety of Dorzolamide 2% When Added to Brimonidine 0.2% or Timolol Maleate 0.5% in Patients with Primary Open-Angle Glaucoma

To determine the ocular hypotensive efficacy and safety of dorzolamide when added to brimonidine or timolol in patients with uncontrolled primary open-angle glaucoma (POAG). This is a 1-year prospective open-label clinical trial of 48 consecutive POAG patients with inadequate intraocular pressure (IOP) control while using brimonidine 0.2% (23 patients) and timolol 0.5% (25 patients), 2 times daily. Patients were assigned to receive dorzolamide 2% as adjunctive therapy, added 3 times daily to brimonidine or timolol. IOP was measured on week 2, and months 3, 6, 9, and 12. A significant reduction in IOP from the baseline was observed after dorzolamide use in both groups at visits during that year (P < 0.001). Overall, mean IOP reduction was 5.6 +/- 1.9 mmHg with the brimonidine-dorzolamide combination, and 6.8 +/- 1.7 mmHg with timolol-dorzolamide after 1 year of treatment; the difference was significant (P = 0.029). No statistical differences existed between the groups for adverse events (P < 0.05). The addition of dorzolamide to brimonidine or timolol has significant IOP-lowering efficacy during 1 year in patients with POAG whose IOPs were inadequately controlled with brimonidine or timolol alone. The IOP-lowering effect of the timolol-dorzolamide combination at 1 year was more pronounced than brimonidine-dorzolamide. Both combinations were well-tolerated by the patients.

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.

Two-year Safety Study of Dorzolamide as Monotherapy and with Timolol and Pilocarpine

To evaluate the safety of open-label 2.0% dorzolamide as monotherapy and when used with timolol and/or pilocarpine for as long as 2 years. The safety of dorzolamide was evaluated in patients with open-angle glaucoma or ocular hypertension over a 2-year period. The incidence of the most common drug-related adverse experiences in the first year was compared with that in the second year using McNemar's test. The ocular hypotensive effect of dorzolamide as monotherapy and with adjunctive therapy was assessed using percent change in intraocular pressure (IOP) from baseline. Of the 304 patients enrolled, 164 (53.9%) continued to receive dorzolamide as monotherapy for 2 years and 140 (46.1%) required add-on therapy. Add-on therapy was initiated by month 6 in 112 of these 140 patients (80%). Of the 304 patients, 202 (66.4%) completed 2 years of therapy. Of the patients who received dorzolamide as monotherapy, drug-related adverse events occurred more frequently during the first year (29.7%) than the second year (13.8%), and the most common ocular drug-related adverse events included conjunctivitis, burning/stinging eye, follicular conjunctivitis, and eyelid edema. After 2 years of therapy, the mean percent decrease in peak IOP was 22.8% for patients receiving dorzolamide monotherapy and 31.2% to 36.0% for patients receiving add-on therapy. Dorzolamide was generally well tolerated for up to 2 years as monotherapy and when used with timolol and/or pilocarpine. Drug-related adverse events were less frequent during the second year of monotherapy than during the first year. Most patients who required add-on therapy did so within the first 6 months of initiating dorzolamide therapy.

The Efficacy and Safety of Dorzolamide as Adjunctive Therapy to Timolol Maleate Gellan Solution in Patients with Elevated Intraocular Pressure

Two parallel, randomized, double-masked, placebo-controlled studies were conducted to assess the efficacy and safety of 2% dorzolamide hydrochloride as adjunctive therapy to 0.5% timolol maleate ophthalmic gellan (gel-forming) solution in patients with elevated intraocular pressure (IOP) that was inadequately controlled with 0.5% timolol maleate gellan solution alone. Both studies began with an open-label 2-week run-in period on 0.5% timolol maleate gellan solution once a day. The only variation in method between the two studies was the dosage of 2% dorzolamide. In one study, 202 patients received 0.5% timolol maleate gellan solution once daily plus either 2% dorzolamide or placebo three times daily. In the other study, 181 patients received 0.5% timolol maleate gellan solution once daily plus either 2% dorzolamide or placebo twice daily. After 85 days, additional mean percent reductions in IOP from baseline at morning trough for the groups receiving 2% dorzolamide three times daily and placebo three times daily were 12.5% and 8.4%, respectively. Mean percent reductions for the groups receiving 2% dorzolamide twice daily and placebo twice daily were 13.1% and 6.5%, respectively. Burning and/or stinging on instillation were the only adverse experiences that affected significantly more of the patients receiving 2% dorzolamide twice or three times daily than those receiving placebo. When administered concomitantly with 0.5% timolol maleate gellan solution, 2% dorzolamide three times daily or twice daily produced a statistically significant reduction in IOP at morning trough and peak and was generally well tolerated.

Long-term Glaucoma Treatment with MK-507, Dorzolamide, a Topical Carbonic Anhydrase Inhibitor

The purpose of this study was to examine the long-term efficacy and safety of dorzolamide (a topical carbonic anhydrase inhibitor, previously known as MK-507) as an ocular hypotensive agent. This open-labeled, multicenter, 52-week trial enrolled patients with primary open-angle glaucoma or ocular hypertension. One percent dorzolamide hydrochloride was instilled in both eyes of each patient every 8 h. On the 1st day of the study, intraocular pressure (IOP) was measured with a Gold-mann applanation tonometer at 8:30 and 10:30 a.m. Patients were examined at least every 4 weeks. During each clinic visit, dorzolamide was given at 12:30 a.m., and IOP was determined 8 h later. After IOP measurements, dorzolamide was administered again. Further IOP readings were taken 2 h later at 10:30 a.m. Patients were monitored closely by testing for visual acuity, anterior segment, and by continuously evaluating symptoms. Ninety-eight patients entered the study and 81 patients (82.7%) completed the study according to the protocol. Three patients had to be withdrawn because of untoward reactions; two experienced ocular discomfort and one developed palpitation. Four patients required additional ocular hypotensive medication for further IOP reduction. One patient was excluded from the analysis because the patient was younger than age 20, which violated the protocol. Dorzolamide significantly reduced IOP by 12.9-17.5% at 8 h after administration and by 16.7-24.1% at 2 h after administration. The IOP decrease was consistent throughout the 52-week trial without waning or potentiation. Our results indicate that dorzolamide may be a safe and effective ocular hypotensive agent.