Ocular hypotensive efficacy and safety of brinzolamide ophthalmic suspension 1% added to travoprost ophthalmic solution 0.004% therapy in patients with open-angle glaucoma or ocular hypertension.

OBJECTIVE

The primary objective of this study was to determine if combined travoprost ophthalmic solution 0.004% and brinzolamide ophthalmic suspension 1% therapy is superior in lowering intraocular pressure (IOP) compared to travoprost monotherapy for patients with open angle glaucoma or ocular hypertension. The secondary objective was to measure the percentage of patients achieving IOP levels of 18 mmHg or less.

STUDY DESIGN AND

METHODS

Single arm, open-label.

PARTICIPANTS

eighty-two patients with inadequate IOP control with travoprost monotherapy.

INTERVENTION: the addition of brinzolamide ophthalmic suspension 1% twice daily.

MAIN OUTCOME MEASURES: The primary endpoint was mean IOP reduction from baseline at 4 and 12 weeks. The percentage of patients who achieved IOP values <or= 18 mmHg was also measured.

RESULTS

The mean age of the patients was 67 years. Ethnic origin was 92.7% Caucasian, 3.7% Black, 2.4% Asian and 1.2% other. The mean duration of travoprost treatment before the trial started was 30 weeks. Compared to the baseline data (IOP = 22.5 mmHg) with travoprost ophthalmic solution 0.004% monotherapy, IOP was decreased after 4 (n = 78) and 12 (n = 71) weeks of combined travoprost and brinzolamide therapy by an average of 3.9 mmHg (17.4%) and 4.2 mmHg (18.4%), respectively. At baseline 6.3% of patients had an IOP of 18 mmHg or less whereas at 4 and 12 weeks, 53.8% and 60.6% of patients respectively had an IOP of 18 mmHg or less. Common adverse events were mild and included ocular hyperaemia, dysgeusia and eye irritation.

STUDY LIMITATIONS: this study had a small sample size and was open-label.

CONCLUSION

Patients receiving combined travoprost ophthalmic solution 0.004% and brinzolamide ophthalmic suspension 1% therapy had lower IOP values compared to those on travoprost monotherapy (p < 0.0001). Combined therapy resulted in a significantly greater percentage of patients achieving IOPs of 18 mmHg or less (p < 0.0001).