Comparison of clinical effects between bromfenac sodium versus loteprednol etabonate following FS-LASIK / 中华实验眼科杂志

Objective To compare the efficacy,safety and tolerability between bromfenac sodium ophthalmic solution 0.1％ eye drop and loteprednol etabonate 0.5％ eye drop after femtosecond laser in situ keratomileusis (FS-LASIK).Methods A prospective randomized controlled trail was performed.Seventy-six patients who had been undergone FS-LASIK in Daping Hospital were enrolled from December 2013 to December 2014.They were divided into two groups randomly by using the random number table method.The bromfenac sodium group included 38 patients administered 0.1％ bromfenac sodium ophthalmic solution,and the loteprednol etabonate group comprised 38 patients treated with 0.5％ loteprednol etabonate.Patients in both groups initially administered tobramycin-dexamethasone four times a day after FS-LASIK for 1 week.Then the patients in the bromfenac sodium group were treated with bromfenac sodium twice a day until 1 month postoperatively.While the patients from the loteprednol etabonate group were treated with loteprednol etabonate twice a day until 1 month after surgery.Visual acuity,refraction,intraocular pressure and ocular manifestation were examined preoperative and 1 day,1 week,1 month,3 months,6 months after FS-LASIK.This study was approved by the medical ethics Committee of Daping Hospital.Results No significant difference was found in the rate of uncorrected visual acuity (UCVA) which achieved to preoperative best corrected visual acuity (BCVA) between the two groups at each time point after operation (x2 =8.000,P =0.613).There was no difference in spherical equivalent (SE) between the two groups postoperatively (Fgroup =1.137,P =0.288),but a significant difference was found between the different time points (Ftime =29.771,P =0.000).Postoperative SE in the two groups tended to have mild hyperopia in the early days,and then gradually tended to " zero" or mild myopia.There was a significant difference with intraocular pressure among different time points (Ftime =87.519,P =0.000),but no significant difference of intraocular pressure was found between the groups (Fgroup =1.989,P =0.161).One month after surgery,the intraocular pressure were higher than 20 mmHg in two eyes in the loteprednol etabonate group,and two eyes were 5 mmHg higher than preoperative intraocular pressure.In bromfenac group,no one was higher than 5 mmHg compared with the preoperative intraocular pressure,and the pressures of all the eyes were lower than 18 mmHg.All the patients in bromfenac group were no drug withdrawal.But three patients were forced to guide drug withdrawal due to high intraocular pressure in loteprednol group.Conclusions Bromfenac sodium is safe,effective and well tolerated after FS-LASIK.

Determination of Loteprednol Etabonate and the Related Substances in Loteprednol Etabonate and Tobra-mycin Compound Ophthalmic Suspension by HPLC with Gradient Elution / 中国药师

Objective:To develop an HPLC with gradient elution method for the determination of loteprednol etabonate and the re-lated substances in loteprednol etabonate and tobramycin compound ophthalmic suspension. Methods:HPLC with gradient elution was performed with Inertsil ph phenyl column (250 mm × 4. 6 mm, 5 μm). The mobile phase A and B was 0. 25% acetic acid solution-acetonitrile (80 ∶20) and acetonitrile, respectively. The flow rate was 2. 0 ml·min-1 and the detection wavelength was 244 nm. The column temperature was 30 ℃ and the injection volume was 20 μl. Results:The main ingredient and the related substances could be well separated. Loteprednol etabonate had a good linear relationship within the range of 0. 001-1. 02 mg·ml-1(r=0. 999 9), and the average recovery was 99. 9%(RSD=0. 9, n=9). Conclusion:The assay method is sensitive, accurate and convenient with good res-olution. It can be applied to control the quality of loteprednol etabonate and tobramycin compound ophthalmic suspension.

Clinical comparison between brachytherapy of 0.5 ％ loteprednol etabonate eye drops and long-term therapy of 0.1％ fluorometholone eye drops after LASEK / 中华实验眼科杂志

Background Conventional corticosteroid therapy after laser epithelial keratomileusis (LASEK) is topical application of 0.1％ fluorometholone eye drops for 4 months,but this therapy increases the ocular hypertension risk and leads to poor compliance in patients.It is necessary to explore a safe and effective brachytherapeutic drug.Objective This study was to compare the clinical outcomes between the brachytherapy of 0.5％ loteprednol etabonate eye drops and the long-term therapy of 0.1％ fluorometholone eye drops after LASEK.Methods Clinical data were retrospectively analyzed from 208 right eyes in 208 mild and moderate myopia patients who received LASEK at Peking University Third Hospital from 2009 to 2013.The eye drops of 0.5％ loteprednol etabonate was used 6 times daily since operation day until postoperative day 5,and 4 times daily for a week,and then tapered for three consecutive weeks in 104 eyes of the loteprednol group after LASEK,and 0.1％ fluorometholone eye drops was applied topically 4 times daily for initial one month and then tapered for three consecutive months in another 104 eyes in the fluorometholone group after LASEK.Corneal epithelial healing time was compared between the two groups by recording the wearing duration of corneal contact lens.Noncontact intraocular pressure (lOP) was detected and corrected 5 days,2 weeks,1 month and 3,6 months after LASEK.Haze was scored based on the criteria of Cheng under the slit lamp microscope and apparently optometry was performed 1 month and 3,6 months after LASEK.Results The number of eyes removed corneal contact lens in 5,6 and 7 days after LASEK was not significantly different between the loteprednol group and the fluorometholone group (x2 =1.180,P =0.554).No considerable differences were seen in the eye numbers with the equivalent spherical lens (absolute value) ≤0.5 D in 1 month,3months and 6 months after LASEK (Z=-1.028,P=0.304;Z=-0.398,P=0.691;Z=-0.445,P=0.656).In the fifth days after surgery,the median corrected IOP was 13.52 mmHg and 13.12 mmHg in the loteprednol group and the fluorometholone group,respectively,showing a significant difference between them (Z =-1.985,P =0.047),but no significant differences were found in IOP in 2 weeks,1 month and 3 months,6 months after surgery between the two groups (all at P＞0.05).IOP elevated (postoperative IOP-preoperative IOP ≥ 5 mmHg) after LASEK in 5 eyes in the loteprednol group and 4 eyes in the fluorometholone group (x2 =0.116,P =0.733).In 1 month after surgery,the number of eyes in different grades of haze was significantly decreased in the loteprednol group compared with the fluorometholone group (x2=13.506,P=0.009),however,there was no significant differences in haze grading in postoperative 3 months and 6 months between the two groups (x2 =2.199,P =0.699;x2 =1.154,P =0.562).Conclusions Brachytherapy of 0.5％ loteprednol etabonate eye drops appears to have a similar effect in antiinflammation and inhibition of haze to the long-term therapy of 0.1％ fluorometholone eye drops after LASEK.Furthermore,topical application of 0.5％ loteprednol etabonate eye drops dose not increase the risk of ocular hypertension.

Long-Term Outcome of Treatment with Topical Corticosteroids for Severe Dry Eye Associated with Sjogren's Syndrome / 전남의대학술지

This retrospective study was performed to analyze the long-term outcome of topical corticosteroid treatment for severe dry eye associated with Sjogren's syndrome (SS). Patients who had severe dry eye associated with SS were topically treated with loteprednol etabonate 0.5% (group A, n=66) or fluorometholone 0.1% (group B, n=67) twice daily and were followed up for 2 years. Visual acuity (VA), intraocular pressure (IOP), Schirmer test, tear film breakup time (BUT), keratoepitheliopathy, and symptom scores were measured at baseline and 6, 12, 18, and 24 months after treatment. VA and IOP were not changed significantly during follow-up in either group. Schirmer test results, keratoepitheliopathy, and symptom scores at 6, 12, 18, and 24 months (p<0.05) and tear film BUT at 12, 18, and 24 months (p<0.05) significantly improved after treatment compared with baseline in both groups. No significant differences between the groups were found in any parameter during follow-up. At 24 months, the number of patients with IOP elevation of more than 2 mmHg compared with baseline was 4 in group A (6.1%) and 9 in group B (13.4%). The mean IOP in these patients was lower in group A than in group B (15.00+/-0.82 mmHg versus 16.50+/-1.12 mmHg; p=0.04). Long-term application of low-dose topical corticosteroids is effective for controlling signs and symptoms of chronic, severe dry eye associated with SS. Loteprednol etabonate 0.5% may have a lower risk for IOP elevation than fluorometholone 0.1%.

Long-Term Outcome of Treatment with Topical Corticosteroids for Severe Dry Eye Associated with Sjogren's Syndrome / 전남의대학술지

This retrospective study was performed to analyze the long-term outcome of topical corticosteroid treatment for severe dry eye associated with Sjogren's syndrome (SS). Patients who had severe dry eye associated with SS were topically treated with loteprednol etabonate 0.5% (group A, n=66) or fluorometholone 0.1% (group B, n=67) twice daily and were followed up for 2 years. Visual acuity (VA), intraocular pressure (IOP), Schirmer test, tear film breakup time (BUT), keratoepitheliopathy, and symptom scores were measured at baseline and 6, 12, 18, and 24 months after treatment. VA and IOP were not changed significantly during follow-up in either group. Schirmer test results, keratoepitheliopathy, and symptom scores at 6, 12, 18, and 24 months (p<0.05) and tear film BUT at 12, 18, and 24 months (p<0.05) significantly improved after treatment compared with baseline in both groups. No significant differences between the groups were found in any parameter during follow-up. At 24 months, the number of patients with IOP elevation of more than 2 mmHg compared with baseline was 4 in group A (6.1%) and 9 in group B (13.4%). The mean IOP in these patients was lower in group A than in group B (15.00+/-0.82 mmHg versus 16.50+/-1.12 mmHg; p=0.04). Long-term application of low-dose topical corticosteroids is effective for controlling signs and symptoms of chronic, severe dry eye associated with SS. Loteprednol etabonate 0.5% may have a lower risk for IOP elevation than fluorometholone 0.1%.

Long-Term Outcome of Treatment with Topical Corticosteroids for Severe Dry Eye Associated with Sjogren's Syndrome / 전남의대학술지

This retrospective study was performed to analyze the long-term outcome of topical corticosteroid treatment for severe dry eye associated with Sjogren's syndrome (SS). Patients who had severe dry eye associated with SS were topically treated with loteprednol etabonate 0.5% (group A, n=66) or fluorometholone 0.1% (group B, n=67) twice daily and were followed up for 2 years. Visual acuity (VA), intraocular pressure (IOP), Schirmer test, tear film breakup time (BUT), keratoepitheliopathy, and symptom scores were measured at baseline and 6, 12, 18, and 24 months after treatment. VA and IOP were not changed significantly during follow-up in either group. Schirmer test results, keratoepitheliopathy, and symptom scores at 6, 12, 18, and 24 months (p<0.05) and tear film BUT at 12, 18, and 24 months (p<0.05) significantly improved after treatment compared with baseline in both groups. No significant differences between the groups were found in any parameter during follow-up. At 24 months, the number of patients with IOP elevation of more than 2 mmHg compared with baseline was 4 in group A (6.1%) and 9 in group B (13.4%). The mean IOP in these patients was lower in group A than in group B (15.00+/-0.82 mmHg versus 16.50+/-1.12 mmHg; p=0.04). Long-term application of low-dose topical corticosteroids is effective for controlling signs and symptoms of chronic, severe dry eye associated with SS. Loteprednol etabonate 0.5% may have a lower risk for IOP elevation than fluorometholone 0.1%.

Effects of Prednisolone and Loteprednol Eyedrops on the Proliferation of Human Tenon's Capsule Fibroblasts

PURPOSE: To compare the effect of loteprednol etabonate (LE) with prednisolone acetate (PDA) drops on the proliferation of human Tenon's capsule fibroblasts (HTFBs). METHODS: Primarily cultured HTFBs were treated with serially diluted PDA and LE for 3 days. Cellular survival was determined by a rapid colorimetric assay using MTT. RT-PCR was performed to determine the relative expression of TGF-beta mRNA in response to LE and PDA. RESULTS: PDA inhibited proliferation of HTCF in a dose-dependent manner and LE inhibited significantly the proliferation of HTCF at the higher concentration of 50 microg/ml (p < 0.05). Compared to LE, PDA inhibited proliferation of HTCF significantly at each diluted concentration (p < 0.05). Expressions of TGF-beta were decreased as the concentration of both PDA and LE increased. PDA decreased expression of TGF-beta more significantly compared to LE at each concentration (p < 0.05). CONCLUSIONS: Although LE has offered promising anti-inflammatory efficacy with decreased impact on intraocular pressure, LE may be less effective than PDA in inhibiting fibroblast proliferation and may be not comparable to PDA in preventing excessive scarring after glaucoma filtering surgery.

Randomized-controlled study on anti-inflammation and safety of three drugs after Nd : YAG laser posterior capsulotomy / 中华实验眼科杂志

Background Nd: YAG laser posterior capsulotomy is an important way for after cataract.Usually the patient will use glucocorticoid eye drops to treat the anterior chamber inflammation after operation,but there is potential risk of elevating intraocular pressure (IOP).Objective This study was to compare the clinical effectiveness and safety of loteprednol etabonate ophthalmic suspension,tobramycin+ dexamethasone eye drops and fluorometholone eye drops following Nd: YAG laser posterior capsulotomy.Methods A randomized-controlled clinical trail was performed.One hundrcd and seventy-onc cycs of 127 paticnts who received Nd: YAG laser posterior capsulotomy for after cataract were randomly divided into four groups.Loteprednol etabonate ophthalmic suspension,fluorometholone eye drops,tobramycin+dexamethasone eye drops and systane eye drops was topically administered respectively in the four groups after laser posterior capsulotomy and 6 times per day for 5 days.IOP was measured with Goldmann tomometer 1 hour before operation and 1 hour,1 day,3 days and 7 days after operation.The ocular anterior segment inflammatory response was examined under the slit lamp and scored based on the Peizeng criteria.Written informed consent was obtained from each patient before any relevant medical procedure.Results The IOP was (18.2 ±4.7),(20.1 ±5.7),(18.7±5.5),(19.0 ±4.1),(19.5 ±3.5) mmHg in various time points in the loteprednol etabonate group; (18.7 ±5.3),(20.9±5.7),(21.3±4.5),(21.0±4.9),(22.5±6.5) mmHg in the fluorometholone eye drops group ; (17.9± 6.3),(20.3 ± 6.1),(23.0 ± 3.7),(24.7 ± 4.9),(24.5 ± 6.5) mmHg in the tobramycin +dexamethasone group and(18.4±6.3),(20.7±3.7),(22.7±6.5),(19.6±4.8),(18.5±3.5) mmHg in the systane group,showing a significant difference among the 4 groups (Fgroup =3.876,P =0.023).With the time lapse,the IOP was gradually reduced in the loteprednol etabonate group and systane group,but that in the fluorometholone group and tobramycin+dexamethasone group was elevated,showing a significant difference among them (Ftime =3.801,P =0.031).No any ocular and systemic adverse effect was found in various groups.The percentage of grade 1 and 2 of aqueous inflammatory cells was lower in the loteprednol etabonate group and tobramycin+dexamethasone group than the fluorometholone group and fluorometholone group and systane group(H =8.276,P =0.012).The percentage of Ⅰgrade of aqueous flare was 8％ in the loteprednol etabonate group,22％ in the fluorometholone group,18％ in the tobramycin+dexamethasone group and 30％ in the systane group,with a significant difference among them (H=9.305,P=0.000).Conclusions The use of corticosteroid eye drops can relieve the inflammatory response of ocular anterior chamber after Nd: YAG laser posterior capsulotomy.Loteprednol etabonate ophthalmic suspension has a better anti-inflammatory effect and less influence on IOP.

A randomized-controlled clinical trial on the application of 0.5％ Ioteprednol etabonate eye drops after myopic laser-assisted in situ keratomileusis surgery / 中华实验眼科杂志

Background It has become a consensus about the necessity of topical administration of corticosteroid eye solutions after myopic laser-assisted in situ keratomileusis(LASIK).The glucocorticoid eye drops with good anti-inflammatory effect and less adverse effects is helpful for the repair of corneal epithelium following LASIK.Objective This study was to evaluate the clinical effects of 0.5％ loteprednol etabonate eye drops after LASIK.Methods A prospective randomized-controlled study was designed.One hundred and twelve myopia patients(224 eyes)who had received LASIK were included in this study and randomly divided into two groups,and 97 patients finished the follow-up,including 108 eyes of 54 patients in the 0.5％ ioteprednol etabonate eye drops treatment group and 86 eyes of 43 patients in the control group.0.5％ loteprednol etabonate eye drops or dexamethasone/tobramycin eye drops were administered topically to the treatment group and control group,respectively 4 times daily from postoperative day 1 through day 7 following LASIK in addition to regular basic treatment.The follow-up was performed 1 day,1 week and 1 month after LASIK.Subjective symptoms including eye pain,foreign body sensation and blurring were scored,and uncorrected visual acuity(UCVA),best corrected visual acuity(BCVA),intraocular pressure(IOP),central corneal thickness,corneal fluorescein staining and diffuse laminar keratitis(DLK)were evaluated and compared between the two groups 1 day,1 week,and 1 month after LASIK.This clinical trial was approved by the Ethic Commission of Zhongshan Ophthalmic Center,and written informed consent was obtained from each patient before the trial.Results No drug-related ocular and systemic adverse events were found in the treatment group throughout the follow-up duration.There was no significant difference in the subjective symptom score after 1 day,1 week and 1 month(P＞0.05).At 1 week post-LASIK,the corrected actual IOP was (16.27±3.31)mmHg in the treatment group and(17.49±4.48)mmHg in the control group,with a statistically significant difference between them(t =-2.113,P =0.036).However,there was no statistically significant difference in IOP between the treatment group(15.01±3.22)mmHg and the control group(15.30±4.17)mmHg at 1 month post-LASIK(t=-0.532,P=0.595).Mild diffuse lamellar keratitis developed in 7 eyes in the treatment group and 5 eyes in the control group without a significant difference on the first day after LASIK(x2 =0.153,P =0.926).The scores of corneal fluorescein staining were not statistically different between the two groups at 1 day,1 week and 1 month postoperative(Z=-0.566,P=0.571 ;Z=-0.689,P=0.491 ;Z=-1.628,P=0.103).Conclusions 0.5％ loteprednol etabonate eye drops could effectively inhibit postoperative inflammation and low the incidence of DLK.It can lessen the risk of IOP elevation in comparison with traditional steroid eye drops.

Gamma Linolenic Acid in Dry Eye

In this prospective study to evaluate the role of gamma linolenic acid in the management of dry eye, 100 patients of dry eyes were studied by dividing randomly into two groups of 50 each. In the test group, all the 50 patients were put on medication which consisted of cap gamma linolenic acid - 120 mg once daily dose, artificial tears solution/ointments 4-6 times daily with a topical mild steroid (loteprednol etabonate 0.5%) thrice daily. In the control group all the 50 patients were put on artificial tear solution/ointments and topical mild steroid (loteprednol etabonate 0.5%) thrice daily. All the patients were subjected to slit lamp examination, schirmer test, and fluorescien stain for tear film break up time (TBUT). In the test group symptomatic relief was shown by all 50 (100%) patients after one week of treatment. There was not much improvement in the schirmer test and TBUT results at 1 week. At 1 month follow up the result showed improvement and at 6 months there was definite increase in the schirmer test & TBUT values. The results were not influenced by the age & gender of the patients. In the control group though there was definite symptomatic relief in all the patients, but there was no change in the major study parameters i.e. tear film meniscus height; schirmer test and TBUT. At six month of the study there was marginal improvement of the major parameters but there was a lot of difference between the test and control groups. Thus gamma linolenic acid has a definite role in the management of dry eye.