The efficacy nd tolerance of topical administration of levocabastine(0.5mg/ml)were evaluated in patients with allergic conjunctivitis. A total of 166 patients who had a typical history of atopy and a positive skin test were recruited in this study. Five clinicl symptoms(itch, tearing, chemosis, lid edema and conjunctival injection) were assessed according to a four point scale before the treatment and at 1 and 2 weeks post-therapy. Total symptom severity score before the therapy, 6.68, was remarkably decreased to 2.86 at 1 week and 2.08 at 2 weeks after the treatment. The investigators rated the treatment as globally good or excellent in 68.1% of patients checked at 1 week and 72.5% at 2 weejs after treatment. And the patients evaluated that the therapy ws good to excellent in 66.9% at 1 week and 73.1% at 2 weeks after treatment. Levocabastine eye drops has a fast onet of action with 55.4% of the patients feeling symptom relief within 15 minutes after the first administration. The adverse effect was experienced in 44 patients. Ocular irritation sign, such as foreign body sensation or soreness, was the most frequently reported complaint. These results suggest that levocabastine eye drops is an effective and safe topical alternative for treatment of allergic conjunctivitis.
Administration, Topical ; Conjunctivitis, Allergic* ; Edema ; Foreign Bodies ; Humans ; Ophthalmic Solutions* ; Research Personnel ; Sensation ; Skin Tests

PURPOSE: To investigate the clinical efficacy of intracameral amphotericin injection and to evaluate risk factors affecting primary treatment success in fungal infection invading the anterior segment of the eye. METHODS: Twenty-six eyes of 26 patients diagnosed with fungal infection in the anterior segment were studied. The initial treatment regimen was a topical 0.15% amphotericin application and itraconazole oral administration after culture. Amphotericin (5 ug/0.1 ml, 0.1 cc) was repeatedly injected intracamerally when the infection intensified. Penetrating keratoplasty was conducted for eyes unresponsive to intracameral amphotericin injection. The relative risk ratios of ulcer size, infiltration depth, culture positivity, and hypopyon were compared in each treatment group to evaluate the treatment response. RESULTS: Of patients with fungal infection, 30.7% were cured with intracameral amphotericin injection, while 30.7% needed penetrating keratoplasty. Intracameral amphotericin injection was needed in the presence of large corneal ulcers (>14 mm2), hypopyon, positive fungal culture, use of steroid eye drops, and deep infiltration at initial examination. Large ulcer size (>14 mm2) was the main risk factor for needing penetrating keratoplasty. Of the eyes Candida infection, 66.5% needed evisceration. CONCLUSIONS: Large ulcer size and the isolation of Candida were poor prognostic factors related to the efficacy of intracameral amphotericin injection.
Administration, Oral ; Amphotericin B* ; Candida ; Humans ; Itraconazole ; Keratoplasty, Penetrating ; Odds Ratio ; Ophthalmic Solutions ; Risk Factors* ; Ulcer

The present study aimed to compare the clinical efficacy of a 0.4% carbomer gel and 1% carboxymethyl cellulose (CMC) containing artificial tears in treatment of dry eye patients. Sixty subjects with mean age of 45.89 years who had symptoms and signs of dry eye were enrolled in this prospective, investigator-masked and stratified random sampling study. The subjects were divided into two parallel groups with 30 subjects (60 eyes) in each group. One group received carbomer gel, and the other group received 1% CMC containing artificial tears. Subjects received the drops 3 to 4 times or more per day for 3 months. At the first visit time, the precorneal residence time of these two drops was measured. The efficacy was assessed by comparing the subjective symptoms (ocular dryness, foreign body sensation, burning sensation and pain), and the objective test results of tears breakup time, Schirmer's test and corneal fluorescein staining prior to the study and after the treatment. As a result, the ocular residence time of carbomer gel was significantly longer than that of 1% CMC (P<0.001). Most of the primary subjective symptoms and objective test results were improved after treatment in both carbomer gel group and 1% CMC group. As to the improvement of each symptom and objective test result, carbomer gel was more effective than 1% CMC group (P<0.01). In conclusion, carbomer gel had longer precorneal residence time and was more effective than 1% CMC in the treatment of patients with dry eyes.
Acrylic Resins/*administration & dosage ; Carboxymethylcellulose Sodium/*administration & dosage ; Dry Eye Syndromes/*drug therapy ; Gels/*administration & dosage ; Ophthalmic Solutions/administration & dosage ; Prospective Studies

OBJECTIVE: To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes. METHODS: The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived. Simulation studies were conducted to evaluate the derived power functions. RESULTS: Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed. The intra-correlation showed a positive correlation with the power of the bioequivalence test. When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval. If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power. Sample size can be calculated through numerical iteration with the derived power functions. CONCLUSION The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.
Administration, Topical ; Clinical Trials as Topic ; methods ; Cross-Over Studies ; Humans ; Models, Theoretical ; Ophthalmic Solutions ; pharmacokinetics ; Sample Size ; Therapeutic Equivalency

This study examined the corneal permeability of topical eye drop solutions added with various corneal penetrating accelerators and gadolinium-diethylene triamine pentaacetic acid (Gd-DTPA) by nuclear magnetic resonance imaging (MRI). Twenty-four New Zealand rabbits were randomly divided into 3 groups according to the random digits table: Gd-DTPA group, in which the rabbits received 23.45% Gd-DTPA; hyaluronic acid group, in which 23.45% Gd-DTPA plus 0.2% hyaluronic acid was administered; azone group, in which 23.45% Gd-DTPA with 0.2% azone was given. Fifty microliters of the eye drops was instilled into the conjunctive sac every 5 min, for a total of 6 applications in each group. Contrast medium signals in the cornea, anterior chamber, posterior chamber, and vitreous body were scanned successively by MRI. The morphology and cell density of the corneal endothelium were examined before and 24 h after the treatment. The results showed that the residence time of Gd-DTPA in the conjunctival sac in the hyaluronic acid and azone groups was longer than that in the Gd-DTPA group. The signals in the anterior chamber of the Gd-DTPA and hyaluronic acid groups were increased slightly, and those in the azone group strengthened sharply. The signal intensity continuously rose over 80 min before reaching plateau. The strengthening rate of signals in the anterior chamber was 19.63% in the Gd-DTPA group, 53.42% in the sodium hyaluronate group, and 226.94% in the azone group. No signal was detected in the posterior chamber or vitreous body in all the 3 groups. Corneal morphology and cell density did not show any significant changes after the treatment in all the 3 groups. It was concluded that azone can significantly improve the corneal permeability of drugs that are similar to Gd-DTPA in molecular weight and molecular size, and MRI is a noninvasive technique that can dynamically detect eye drop metabolism in real time.
Animals ; Azepines ; administration & dosage ; pharmacokinetics ; Contrast Media ; administration & dosage ; pharmacokinetics ; Cornea ; metabolism ; Female ; Gadolinium DTPA ; administration & dosage ; pharmacokinetics ; Magnetic Resonance Imaging ; Male ; Ophthalmic Solutions ; Permeability ; Rabbits

OBJECTIVETo investigate the efficiency of Spanishneedles Herb eye drops in treating perimenopausal xerophthalmia in rabbits.

METHODTotally 36 rabbits (36 right eyes) were ovariectomized, and 2 months later divided into three groups: the experimental group (group A, n = 12) given Spanishneedles Herb eye drops, the control group (group B, n = 12) given PBS and the model group (group C, n = 12) given no drug. The Schirmer I test (SIT), fluorescent (FL), total tear protein, diastase activity, lactoferrin and lysozyme contents and confocal scanning microscopy were performed at before the treatment and at 1 w, 2 w, 1 mo, 2 mo after the treatment.

RESULTBefore the treatment, There was no significant difference in SIT, FL, total tear protein, lysozyme, lactoferrin and amylase activity between two groups. Two months later after the treatment, both the group B and the group A showed differences degrees of changes in SIT, FL, total tear protein, lysozyme, lactoferrin and amylase activity compared with that before the treatment, with statistical differences (P < 0.05); At each time point, both groups revealed statistical differences in SIT, FL, total tear protein, lysozyme, lactoferrin and amylase activity (1 < 0.05). Two months later alter the treatment, densities of basal epithelial cells and inflammatory cells in the group A were (4 122 ±416) cells/mm2 and (339 ± 131) cells/mm2, while that in the group B were (3 343 ± 424) cells/mm2 and (49 ± 17) cells/mm2, with statistical differences between them (P < 0.05).

CONCLUSIONSpanishneedles Herb eye drops could effectively treat perimenopausal xerophthalmia in rabbit caused by sex hormones decline.

Animals ; Asteraceae ; chemistry ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Ophthalmic Solutions ; administration & dosage ; Perimenopause ; drug effects ; metabolism ; Rabbits ; Tears ; secretion ; Xerophthalmia ; drug therapy ; metabolism

We studied the efficacy and safety of using topical mitomycin C (MMC) as an adjunct to glaucoma filtration surgery. Trabeculectomy was performed in 23 eyes of 19 patients with poor surgical prognosis. After the preparation of a scleral flap, 0.2 mg or 0.4 mg/ml MMC was applied to the exposed tissue for 5 minutes. The wound was then irrigated with 250ml of normal saline. The mean follow-up period was 7.8 months. Preoperative mean intraocular pressure (IOP) was 33.8mmHg, and the mean IOPs on 1, 3, 6, and 12 months after operation were 10.3, 12.5, 12.4 and 12.3mmHg, respectively. At postoperative 12 months, 74.7% achieved an IOP of less than or equal to 20mmHg without any antiglaucoma medication. There were early postoperative complications of aqueous leaking from conjunctival wounds in 3 eyes (13.0%), shallow anterior chamber in 2 eyes, and hyphema in one eye and one eye had long-term hypotony lasting more than 3 months. Although MMC is simple to use, it is a potent adjunct to glaucoma filtration surgery, more work should follow to determine the mechanism of action, indications, dosage and optimal exposure time of MMC.
Administration, Topical ; Adolescent ; Adult ; Aged ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Glaucoma/surgery/*therapy ; Humans ; Intraocular Pressure ; Male ; Middle Aged ; Mitomycin/*administration & dosage ; Ophthalmic Solutions ; Prognosis ; *Trabeculectomy

Posterior lip sclerectomies were performed in rabbits and cytosine arabinoside (Ara-C) was applied by topical instillation or subconjunctival injection. In both groups, the mean intraocular pressure (IOP) of the treated eyes was significantly lowered at postoperative week 1 and 2, but there was no significant difference between the mean IOP of the control eyes and that of the treated eyes at postoperative week 3 and 4. In both groups, at postoperative week 2, the sclerectomy sites of the control eyes were totally occluded by granulation tissue, but those of the treated eyes were partially replaced by granulation tissue. At postoperative week 4, the sclerectomy sites of the treated eyes were totally occluded by the granulation tissue ultimately in both groups. There were no differences in the mean IOP and the histologic finding of the treated eyes between the topical instillation group and the subconjunctival injection group. We concluded that either topical instillation or subconjunctival injection of Ara-C can delay wound healing at the surgical site after glaucoma filtering surgery in rabbits.
Administration, Topical ; Animals ; Conjunctiva ; Cytarabine/*administration & dosage/therapeutic use ; Glaucoma/pathology/*surgery ; Injections ; Intraocular Pressure/drug effects ; Ophthalmic Solutions ; Rabbits ; *Sclerostomy ; Wound Healing/drug effects

The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 microg.mL(-1) could be measured in 1.6667 mg.mL(-1) ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0. 999 9) and precise (RSD = 0. 70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.
Anti-Bacterial Agents ; administration & dosage ; analysis ; pharmacology ; Azithromycin ; administration & dosage ; analysis ; pharmacology ; Bacillus subtilis ; drug effects ; Microbial Sensitivity Tests ; Ophthalmic Solutions ; chemistry ; Quality Control

Acanthamoeba Keratitis ; diagnosis ; drug therapy ; Anti-Inflammatory Agents, Non-Steroidal ; administration & dosage ; Atropine ; administration & dosage ; Cornea ; pathology ; Diagnosis, Differential ; Diclofenac ; administration & dosage ; Drug Administration Schedule ; Drug Therapy, Combination ; Follow-Up Studies ; Humans ; Mydriatics ; administration & dosage ; Ophthalmic Solutions ; Retrospective Studies