Tags

Type your tag names separated by a space and hit enter

Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study.
BMC Ophthalmol. 2014 Dec 19; 14:161.BO

Abstract

BACKGROUND

Fixed-combination ocular hypotensives have multiple advantages, but triple-therapy dorzolamide/brimonidine/timolol (dorz/brim/tim) is only available in Latin and South America, and information on its relative efficacy is limited. This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol (bim/tim) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension.

METHODS

In this investigator-masked, crossover study, patients with unmet target intraocular pressure (IOP) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3 months before returning to their pre-baseline medication for 3 months. IOP was evaluated before and after morning instillation at months 2, 3, 5 and 6. Primary endpoints were mean IOP change and Ocular Surface Disease Index© (OSDI) score at each visit. The intent-to-treat population was the a priori analysis population, but due to the number of discontinuations, the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses, respectively.

RESULTS

Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations, respectively. At month 3, statistically significant IOP reductions from baseline were observed in the bim/tim (P < 0.01) and dorz/brim/tim (P < 0.0001) groups, regardless of assessment time. At month 6, patients returned to bim/tim exhibited no significant IOP increase (regardless of assessment time), but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase (P < 0.001) when assessed before instillation of study treatment. Results were similar in both intent-to-treat and per-protocol analysis populations. In the per-protocol analysis, 70% of patients on bim/tim at month 3 had an IOP <14 mm Hg, which declined to 58% (P = 0.0061) at month 6 (ie, after 3 months of dorz/brim/tim treatment). In patients receiving dorz/brim/tim at month 3, 38% had an IOP <14 mm Hg, which remained comparable after return to bim/tim. OSDI scores and incidence of adverse events were similar in both groups.

CONCLUSIONS

In this first direct comparison of the efficacy of dorz/brim/tim and bim/tim, patients switched from dorz/brim/tim to bim/tim demonstrated improved/lower IOP; when returned to dorz/brim/tim, IOP increased to levels seen at study initiation, suggesting that once-daily bim/tim may have greater IOP-lowering efficacy. Both bim/tim and dorz/brim/tim were well tolerated with minimal ocular surface damage.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT01737853 (registered October 9, 2012).

Authors+Show Affiliations

Fundación Hospital de Nuestra Señora de la Luz, Ezequiel Montes #135 C,P, 06030 Del, Cuauhtémoc, México City, D,F,, México. alfonsogarl@mac.com.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25527295

Citation

García-López, Alfonso, et al. "Efficacy and Tolerability of Fixed-combination Bimatoprost/timolol Versus Fixed-combination Dorzolamide/brimonidine/timolol in Patients With Primary Open-angle Glaucoma or Ocular Hypertension: a Multicenter, Prospective, Crossover Study." BMC Ophthalmology, vol. 14, 2014, p. 161.
García-López A, Paczka JA, Jiménez-Román J, et al. Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study. BMC Ophthalmol. 2014;14:161.
García-López, A., Paczka, J. A., Jiménez-Román, J., & Hartleben, C. (2014). Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study. BMC Ophthalmology, 14, 161. https://doi.org/10.1186/1471-2415-14-161
García-López A, et al. Efficacy and Tolerability of Fixed-combination Bimatoprost/timolol Versus Fixed-combination Dorzolamide/brimonidine/timolol in Patients With Primary Open-angle Glaucoma or Ocular Hypertension: a Multicenter, Prospective, Crossover Study. BMC Ophthalmol. 2014 Dec 19;14:161. PubMed PMID: 25527295.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study. AU - García-López,Alfonso, AU - Paczka,José A, AU - Jiménez-Román,Jesús, AU - Hartleben,Curt, Y1 - 2014/12/19/ PY - 2014/07/03/received PY - 2014/12/12/accepted PY - 2014/12/21/entrez PY - 2014/12/21/pubmed PY - 2015/5/13/medline SP - 161 EP - 161 JF - BMC ophthalmology JO - BMC Ophthalmol VL - 14 N2 - BACKGROUND: Fixed-combination ocular hypotensives have multiple advantages, but triple-therapy dorzolamide/brimonidine/timolol (dorz/brim/tim) is only available in Latin and South America, and information on its relative efficacy is limited. This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol (bim/tim) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension. METHODS: In this investigator-masked, crossover study, patients with unmet target intraocular pressure (IOP) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3 months before returning to their pre-baseline medication for 3 months. IOP was evaluated before and after morning instillation at months 2, 3, 5 and 6. Primary endpoints were mean IOP change and Ocular Surface Disease Index© (OSDI) score at each visit. The intent-to-treat population was the a priori analysis population, but due to the number of discontinuations, the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses, respectively. RESULTS: Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations, respectively. At month 3, statistically significant IOP reductions from baseline were observed in the bim/tim (P < 0.01) and dorz/brim/tim (P < 0.0001) groups, regardless of assessment time. At month 6, patients returned to bim/tim exhibited no significant IOP increase (regardless of assessment time), but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase (P < 0.001) when assessed before instillation of study treatment. Results were similar in both intent-to-treat and per-protocol analysis populations. In the per-protocol analysis, 70% of patients on bim/tim at month 3 had an IOP <14 mm Hg, which declined to 58% (P = 0.0061) at month 6 (ie, after 3 months of dorz/brim/tim treatment). In patients receiving dorz/brim/tim at month 3, 38% had an IOP <14 mm Hg, which remained comparable after return to bim/tim. OSDI scores and incidence of adverse events were similar in both groups. CONCLUSIONS: In this first direct comparison of the efficacy of dorz/brim/tim and bim/tim, patients switched from dorz/brim/tim to bim/tim demonstrated improved/lower IOP; when returned to dorz/brim/tim, IOP increased to levels seen at study initiation, suggesting that once-daily bim/tim may have greater IOP-lowering efficacy. Both bim/tim and dorz/brim/tim were well tolerated with minimal ocular surface damage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01737853 (registered October 9, 2012). SN - 1471-2415 UR - https://www.unboundmedicine.com/medline/citation/25527295/Efficacy_and_tolerability_of_fixed_combination_bimatoprost/timolol_versus_fixed_combination_dorzolamide/brimonidine/timolol_in_patients_with_primary_open_angle_glaucoma_or_ocular_hypertension:_a_multicenter_prospective_crossover_study_ L2 - https://bmcophthalmol.biomedcentral.com/articles/10.1186/1471-2415-14-161 DB - PRIME DP - Unbound Medicine ER -