PURPOSE: To evaluate and compare the efficacy and safety of cyclosporine 0.05% (Cyporin N eye drops 0.05%) to an active comparator (Restasis®) in moderate to severe dry eye patients. METHODS: This is a multicenter, randomized, double-blind, parallel, active control, non-inferiority, phase III study. Patients had a 2-week run-in period (during the run-in period, patients used artificial tears, if applicable), and afterward 158 patients were randomly assigned treatment for 12 weeks with cyclosporine 0.05% (with artificial tears, if applicable), in which the efficacy and safety were evaluated every four weeks. RESULTS: Corneal staining tests showed that in the per protocol set group, the study group was not inferior to the control group; the results for the full analysis set analytic group were the same. The number of adverse events reported from the 158 patients was not significantly different between groups (p = 0.1107). Additionally, other evaluations, including tolerability evaluations, clinical pathology examinations, and vital signs, show that there is no difference in terms of safety between the groups. CONCLUSIONS: Cyclosporine A 0.05% (Cyporin N eye drops 0.05%) is considered to have the same efficacy and safety compared to the active comparator.
Cyclosporine* ; Dry Eye Syndromes ; Humans ; Lubricant Eye Drops ; Ophthalmic Solutions ; Pathology, Clinical ; Vital Signs

PURPOSE: In this study, the changes in ocular surface parameters and tear meniscus after strabismus surgery when treated with or without artificial tears were evaluated using optical coherence tomography (OCT). METHODS: The present study included 30 patients who received bilateral lateral rectus recession surgery for exotropia. The patients instilled artificial tear eye drops only in the left eye. Before and 2, 4, 8, and 12 weeks after surgery, tear film break-up time (BUT), Schirmer's test, corneal staining test, tear meniscus height and area were measured using OCT and compared in both eyes. Before and 8 weeks after surgery, conjunctival compression cytology test was performed. RESULTS: The mean patient age was 8.7 years. After 8 weeks, BUT and corneal staining scores were 12.3 ± 1.5 seconds and 1.3 ± 0.4 in patients treated with artificial tears and 9.5 ± 1.0 seconds and 2.0 ± 0.7 in patients not treated with artificial tears (both p < 0.000). Four weeks after surgery, tear meniscus height and area using OCT were 290.2 ± 42.3 µm and 566.7 ± 48.2 pixels in patients treated with artificial tears and 246 ± 45.5 µm and 504.0 ± 29.7 pixels in patients not treated with artificial tears (p = 0.045 and p = 0.019, respectively). Goblet cell count was significantly different between the eyes 8 weeks after surgery (p = 0.033). CONCLUSIONS: Instability of tear meniscus can be detected after strabismus surgery using BUT, Schirmer's test, corneal staining test, tear meniscus height and area, and OCT. After surgery, artificial tears help treat dry eye symptoms by corneo-conjunctival wound healing mechanism and increasing tear meniscus stability.
Exotropia ; Goblet Cells ; Humans ; Lubricant Eye Drops ; Ophthalmic Solutions ; Strabismus* ; Tears* ; Tomography, Optical Coherence* ; Wound Healing

PURPOSE: To report a case series of patients experiencing side effects of 0.25% alcaftadine eye drops and to analyze the possible reasons for the side effects. CASE SUMMARY: Medical records of 90 patients who had a history of alcaftadine eye drop use were retrospectively analyzed. Eight out of the 90 patients (8.9%) showed ocular side effects that required discontinuation of the alcaftadine eye drops. All eight cases of alcaftadine side effects showed palpebral and bulbar conjunctival injection, watery discharge, and lid swelling. During additional history collection, all patients with alcaftadine side effects confessed of overuse (more than twice/day) of the eye drops. Anticipation for fast symptom relief was the main reason for the alcaftadine overuse. In all side effect cases, patients were asked to stop alcaftadine eye drops and use preservative-free artificial tears and steroid eye drops. After discontinuation of 0.25% alcaftadine eye drops, regression of palpebral and bulbar conjunctival injection and lid swelling was observed. CONCLUSIONS: Overuse of 0.25% alcaftadine eye drops can induce ocular surface toxicity possibly due to toxicity of drug itself. The possible side effects of overuse of 0.25% alcaftadine eye drops should be fully explained to all patients before use.
Conjunctivitis ; Humans ; Hypersensitivity ; Lubricant Eye Drops ; Medical Records ; Ophthalmic Solutions ; Retrospective Studies

PURPOSE: The changes in tear film lipid layer thickness (LLT) after artificial tears application using LipiView®II interferometer were assessed. METHODS: We performed a prospective study of patients with dry eye disease. All subjects underwent measurement of tear film break-up time, Schirmer test, ocular surface staining, meibomian gland evaluation, and subjective score assessment using the Ocular Surface Disease Index. All subjects were randomly assigned to 1 of 3 groups using table of random numbers (group 1, sodium hyaluronate [HA] 0.1% eye drops without preservatives; group 2, HA 0.3% eye drops without preservatives and group 3, HA 0.1% with benzalkonium chloride 0.003%). LLT was measured before, immediately after and 1 hr, 3 hrs, and 6 hrs after artificial tears application. Additionally, the patients were divided into 2 subgroups depending on the presence of meibomian gland dysfunction (MGD) and further evaluated. RESULTS: Significant change in LLT was observed at 3 hrs after artificial tears instillation. LLT in groups 1 and 2 showed significant changes over time (p < 0.01 and p < 0.01, respectively). However, LLT in group 3 showed no change. LLT was unchanged in patients without MGD. Conversely, in MGD patients, a significant difference in LLT between groups 1 and 2 was observed immediately after and 1 hr and 3 hrs after instillation of artificial tears (p = 0.04, p < 0.01 and p = 0.02, respectively) but not at 6 hrs. However, no significant difference in LLT between groups 1 and 3 was observed in MGD patients. CONCLUSIONS: LLT after instillation of artificial tears measured using LipiView®II interferometer was affected by artificial tear concentration and presence of preservatives. Additionally, the presence of MGD can impact the pattern of LLT changes induced by artificial tear instillation. Therefore, LLT measurements using LipiView®II interferometer require at least a 6-hrs interval after use of eye drops, especially for patients with MGD or using artificial tears with preservatives.
Benzalkonium Compounds ; Eye Diseases ; Humans ; Hyaluronic Acid ; Lubricant Eye Drops ; Meibomian Glands ; Ophthalmic Solutions ; Prospective Studies ; Tears*

Establishing the formulation of 0.1% diclofenac eye drops by making up solution and quantitative by High- Performance Liquid Chromatography (HPLC). Results: Natri diclofenac eye drop 0.1% mixing with phosphate buffer 0.05M get the most stability at pH=7.5. The percentage of propylene glycol and natrimetabisulfit in the formulation influenced significantly the stability of eye drop solution. The stability increased gradually if the rates of natri metabisulfit antioxygen are 0.1%; 0.2% and 0.3% or there was an increase of propylene glycol with the rate of 0%, 5% and 10%. This preparation is stable at least 5 months at temperature 50oC and protected from light. This preparation may be stable more than 20 months at room conditions 30oC and protected from light
Ophthalmic Solutions ; Diclofenac

The factors selected as an independent variable to study included antioxidant dinatri EDTA and viscosity enhancers PVP. Value of pH and percent of remained tobramycine contents after 3 months with ageing at 500C compared with primary tobramycine were selected as a dependent variable. Experimental model was designed according to model of quadratic equation including 9 formulas. The relationship between independent variables X and dependent variables Y conformed to quadratic regressive equation. Base on preliminary formulas selected, Modde 5.0 software was used to trace experimentally and deal with the results. Optimal formula of tobramycine eye drop 0.3% had stableness over 3 months at 50oC and over 12 months at normal condition
Ophthalmic Solutions ; Tobramycin

The results of study showed no significant differences on the stability of eye drop preparation containing vitamin B5 kept in neutral glass bottle and in PE vial. Light and high temperature make impact on the stability of the preparation so it needs to be kept from light in a cool place. With selected formula, the eye drop containing vitamin B5 kept in PE vial has stability at least 12 months at room conditions
Ophthalmic Solutions ; Pantothenic Acid

PURPOSE: To report a case of conjunctival lithiasis with clinical manifestations of superior limbic keratoconjunctivitis. CASE SUMMARY: A 40-year-old male complained of pain, foreign body sensation and injection in the left eye lasting 1 month. The slit-lamp examination revealed injection of the superior bulbar conjunctiva, linear corneal band opacity, fine punctate staining and epithelial defect in the superior cornea area. After eversion of the left upper eyelid, there were many various-sized conjunctional concretions and inflammation in the superior tarsal conjunctiva. Therefore, we considered conjunctival lithiasis-induced clinical manifestations of superior limbic keratoconjunctivitis and then removed the conjunctival concretions using a 30-gauge needle. After the procedures, artificial tears, antibiotic eye drops, steroid eye drops and a therapeutic contact lens were applied. After 1 week, all symptoms and signs improved and there was no recurrence for 4 months. CONCLUSIONS: Mechanical stimulation by severe conjunctival lithiasis can induce clinical manifestations of superior limbic keratoconjunctivitis. Therefore, in patients with clinical manifestations of superior limbic keratoconjunctivitis, conjunctival lithiasis should be considered by observing the superior tarsal conjunctiva more closely.
Adult ; Conjunctiva ; Cornea ; Eyelids ; Foreign Bodies ; Humans ; Inflammation ; Keratoconjunctivitis* ; Lithiasis* ; Lubricant Eye Drops ; Male ; Needles ; Ophthalmic Solutions ; Recurrence ; Sensation

No abstract available.
Dermatitis, Allergic Contact* ; Ophthalmic Solutions*

Study on some influencing factors such as buffer, antioxidant substances to build primary formulation of tobramycin eye drops with stability over 12 months. Result: temperature and light have much influence to the stability of tobramycin and pH contents of eye drops solution. High temperature impacts clearly to the decrease of tobramycin pH and contents. The solution was stable with borate buffer more than phosphate and citrate buffer. Product samples without antioxidant substances have low remained tobramycin contents, about 70% after three months ageing. Dinatri EDTA, natri bisulfit and dinatri EDTA-natri bisulfit combination have significant effect to the stable of tobramycin content. However, dinatri EDTA choice compared with dinatri EDTA-natri bisulfit combination is the same because of dinatri EDTA effect. Dinatri EDTA has better effect to the stable of pH and increase anti-bacteria effect of benzalkonium chloride
Ophthalmic Solutions ; Tobramycin ; Drug Stability