PURPOSE: To evaluate the demographic and clinical characteristics of bimatoprost-induced periocular skin hyperpigmentation. METHODS: The chart analyses of 16 patients in whom cosmetically noticeable periocular skin hyperpigmentation developed after starting bimatoprost therapy were reviewed. Data collated included age, medication history, dates of starting and stopping bimatoprost treatment, and the subjective assessment of the periocular hyperpigmentation at initial detection as well as follow-up visits. Periocular hyperpigmentation was graded using an arbitrary scale from 0 to 3. The number of days to the onset of hyperpigmentation and to pigment resolution was determined and their associations to demographic and other clinical parameters were analyzed. RESULTS: Patients had variable grades of periocular hyperpigmentation at presentation (mean, 1.53+/-0.66). Bimatoprost-induced periocular hyperpigmentation appeared 1-10 (mean, 4.3+/-2.6) months after initiation of bimatoprost therapy. Resolution of skin hyperpigmentation was noted 2-10(mean 6.8+/-1.9) months after stopping bimatoprost treatment. There was a minor correlation(R=+0.19) between the number of days to resolution of hyperpigmentation and the number of days when bimatoprost was used. At 12 months after stopping bimatoprost treatment, 12 of the 13 patients had complete resolution of periocular hyperpigmentation. However, weak hyperpigmentation remained in one patient. CONCLUSIONS: Bimatoprost-induced hyperpigmentation is benign and reversible.
Follow-Up Studies ; Humans ; Hyperpigmentation* ; Skin* ; Bimatoprost

PURPOSE: To report two cases of deepening of the upper lid sulcus following bimatoprost. METHODS: A 54-year-old woman who used bimatoprost for one week and a 70-year-old woman who used bimatoprost for 4 months developed deep lid sulcus. Both were using bimatoprost for glaucoma treatment. RESULTS: Both patients also showed improvement of dermatochalasis and widening of the palpebral fissure. One week after discontinuing bimatoprost, the lid sulcus of the 54-year-old returned to baseline and exophthalmometry was unchanged. The orbital CT of the 70-year-old was normal. She did not complain about deepening of the lid sulcus, and she has not discontinued treatment due to this adverse effect.
Aged ; Female ; Glaucoma ; Humans ; Middle Aged ; Orbit ; Bimatoprost

PURPOSE: To investigate the effects of bimatoprost on the permeability of cultured human trabecular meshwork cells (HTMC) monolayer. METHODS: HTMCs were cultured until confluency in the inner Transwell chamber and then exposed to benzalkonium chloride, brimonidine, latanoprost or bimatoprost for 1 week. Carboxyfluorescein permeability through the HTMC monolayer was measured using a spectrofluorometer after 2 hours in the outer chamber. Cellular viability was assessed using the MTT assay. RESULTS: Each drug diluted at 1/1000X did not affect the cellular survival (p > 0.05). Brimonidine, latanoprost and bimatoprost did not affect the carboxyfluorescein permeability through the HTMC monolayer (p > 0.05). The carboxyfluorescein permeability was not different between latanoptost and bimatoprost after 1 week of exposure (p > 0.05). CONCLUSIONS: Bimatoprost, a drug known to increase trabecular outflow, does not affect the carboxyfluorescein permeability through the HTMC monolayer. Thus, the effect on the trabecular outflow of bimatoprost may not be significant.
Benzalkonium Compounds ; Humans ; Permeability* ; Trabecular Meshwork* ; Bimatoprost ; Brimonidine Tartrate

PURPOSE: To demonstrate the effects of bimatoprost on the optic nerve head (ONH) and peripapillary retinal blood flow. METHODS: Sixteen healthy volunteers were recruited. In a randomized, double-blind design, one eye received a drop of bimatoprost and the other eye a drop of placebo. ONH and peripapillary retinal blood flow parameters (flow, volume, velocity) were measured with HRF before, and at 1, 6 and 24 hours after eyedrops and blood pressure (BP), heart rate (HR), and intraocular pressure (IOP) were recorded. RESULTS: The 16 subjects comprised 13 males and 3 females with a mean age of 27.3 +/- 2.4 years. IOP decreased significantly in the bimatoprost-treated eyes at 1, 6 and 24 hours after eyedrops (p<0.05). BP and HR were unchanged after bimatoprost eyedrops. The flow was significantly higher in the temporal peripapillary retina in the bimatoprost-treated eyes 1 hour after eyedrops and the velocity was also higher 6 hours after eyedrops at the same location. At the optic disc, there was a significant increase of the volume in the bimatoprost group 1 hour after eyedrops. There was no significant decrease of HRF parameters in the bimatoprost-treated eyes. CONCLUSIONS: These results suggest that bimatoprost does not have any adverse effect on ONH or peripapillary retinal blood flow.
Blood Pressure ; Female ; Healthy Volunteers ; Heart Rate ; Humans ; Intraocular Pressure ; Male ; Ophthalmic Solutions ; Optic Disk* ; Optic Nerve* ; Retina ; Retinaldehyde* ; Bimatoprost

PURPOSE: To evaluate the effects of prostaglandin analogues on the corneal thickness of patients with primary open-angle glaucoma (POAG) or normal tension glaucoma (NTG). METHODS: This study included 130 eyes of 65 patients who were diagnosed with POAG or NTG. All patients were divided into two groups; one group received prostaglandin analogues, while the other group received alternative ocular hypotensive eyedrops. Corneal thickness, best corrected visual acuity, and flare in the anterior chamber were measured and compared before treatment and at least 24 months (mean: 27 months) after treatment. RESULTS: The mean decrease in corneal thickness was statistically significant in the group using prostaglandin analogues, but not in the control group. Among the various prostaglandin analogues used, travoprost and latanoprost decreased mean corneal thickness, but bimatoprost had no effect. Best corrected visual acuity, refraction power, and flare in the anterior chamber did not change significantly in either group of patients when ocular hypotensive eyedrops were used. CONCLUSIONS: Prostaglandin analogues lower intraocular pressure and decrease corneal thickness if used over a 24 months.
Amides ; Anterior Chamber ; Cloprostenol ; Eye ; Glaucoma, Open-Angle ; Humans ; Intraocular Pressure ; Low Tension Glaucoma ; Ophthalmic Solutions ; Prostaglandins F, Synthetic ; Prostaglandins, Synthetic ; Visual Acuity ; Bimatoprost ; Travoprost

BACKGROUNDLowering intraocular pressure (IOP) is currently the only therapeutic approach in primary open-angle glaucoma. and the fixed-combination medications are needed to achieve sufficiently low target IOP. A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China. In this study, we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension.

METHODSIn this multicenter, randomized, double-masked, parallel controlled study, patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical β-blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1:1 ratio at 11 Chinese ophthalmic departments. Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03% bimatoprost and 0.5% timolol (followed by vehicle for masking) once daily at 19:00 P.M. and concurrent treatment was 0.03% bimatoprost followed by 0.5% timolol once daily at 19:00 P.M. The primary efficacy variable was change from baseline in mean diurnal intraocular pressure (IOP) at week 4 visit in the intent-to-treat (ITT) population. Primary analysis evaluated the non-inferiority of bimatoprost/ timolol fixed combination to concurrent with respect to the primary variable using a confidence interval (CI) approach. Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95% CI for the between-treatment (bimatoprost/timolol fixed combination minus concurrent) difference was ≤ 1.5 mmHg. Adverse events were collected and slit-lamp examinations were performed to assess safety. Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher's exact test.

RESULTSOf the enrolled 235 patients, 121 patients were randomized to receive bimatoprost/timolol fixed combination and, 114 patients were randomized to receive concurrent treatment. At baseline the mean value of mean diurnal IOP was (25.20 ± 3.06) mmHg in the bimatoprost/timolol fixed combination group and (24.87 ± 3.88) mmHg in the concurrent group. The difference between the treatment groups was not statistically significant. The mean change from baseline in mean diurnal IOP (± standard deviation) in the bimatoprost/timolol fixed combination group was (-9.38 ± 4.66) mmHg and it was (-8.93 ± 4.25) mmHg in the concurrent group (P < 0.01). The difference between the two treatment groups (bimatoprost/timolol fixed combination minus concurrent) in the change from baseline of mean diurnal IOP was -0.556 mmHg (95% CI: -1.68, 0.57, P = 0.330). The upper limit of the 95% CI was less than 1.5 mmHg, the predefined margin of non-inferiority. Adverse events occurred in 26.4% (32/121) of the bimatoprost/timolol fixed combination patients and 30.7% (35/114) of the concurrent patients. The most frequent adverse event was conjunctival hyperemia, which was reported as treatment related in 16.5% (20/121) in the bimatoprost/timolol fixed combination group and 18.4% (21/114) in the concurrent group (P > 0.05).

CONCLUSIONSBimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components. Safety profiles were similar between the treatment groups.

Adolescent ; Adult ; Aged ; Amides ; administration & dosage ; adverse effects ; therapeutic use ; Bimatoprost ; Cloprostenol ; administration & dosage ; adverse effects ; analogs & derivatives ; therapeutic use ; Female ; Glaucoma, Open-Angle ; drug therapy ; Humans ; Male ; Middle Aged ; Ocular Hypertension ; drug therapy ; Timolol ; administration & dosage ; adverse effects ; therapeutic use ; Young Adult

PURPOSE: To compare the efficacy and safety of latanoprost, bimatoprost, travoprost and timolol in reducing intraocular pressure (IOP) in patients with primary open angle glaucoma. METHODS: This was a prospective study conducted at a tertiary-care centre. One hundred and forty patients with newly diagnosed primary open angle glaucoma were randomly assigned to treatment with latanoprost (0.005%), bimatoprost (0.03%), travoprost (0.004%) or timolol gel (0.5%); 35 patients were assigned to each group. All patients were followed for 2, 6, and 12 weeks. The main outcome measure studied was the change in IOP at week 12 from the baseline values. Safety measures included recording of adverse events. RESULTS: The mean IOP reduction from baseline at week 12 was significantly more with bimatoprost (8.8 mmHg, 35.9%) than with latanoprost (7.3 mmHg, 29.9%), travoprost (7.6 mmHg, 30.8%) or timolol (6.7 mmHg, 26.6%) (ANOVA and Student's t-tests, p < 0.001). Among the prostaglandins studied, bimatoprost produced a maximum reduction in IOP (-2.71; 95% confidence interval [CI], -2.25 to -3.18) followed by travoprost (-1.27; 95% CI, -0.81 to -1.27) and latanoprost (-1.25; 95% CI, -0.79 to -1.71); these values were significant when compared to timolol at week 12 (Bonferroni test, p < 0.001). Latanoprost and travoprost were comparable in their ability to reduce IOP at each patient visit. Ocular adverse-events were found in almost equal proportion in patients treated with bimatoprost (41.3%) and travoprost (41.9%), with a higher incidence of conjunctival hyperemia (24.1%) seen in the bimatoprost group. Timolol produced a significant drop in heart rate (p < 0.001) at week 12 when compared to the baseline measurements. CONCLUSIONS: Bimatoprost showed greater efficacy when compared to the other prostaglandins, and timolol was the most efficacious at lowering the IOP. Conjunctional hyperemia was mainly seen with bimatoprost. However, the drug was tolerated well and found to be safe.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antihypertensive Agents/adverse effects/*therapeutic use ; Bimatoprost/adverse effects/therapeutic use ; Blood Pressure/drug effects ; Female ; Glaucoma, Open-Angle/*drug therapy/physiopathology ; Heart Rate/drug effects ; Humans ; Intraocular Pressure/drug effects ; Male ; Middle Aged ; Prostaglandins F, Synthetic/adverse effects/therapeutic use ; Timolol/adverse effects/therapeutic use ; Tonometry, Ocular ; Travoprost/adverse effects/therapeutic use ; Treatment Outcome ; Visual Acuity/drug effects ; Visual Field Tests ; Visual Fields/drug effects