In vitro release of CsA from different proliposomes and a commercial product Restasis® (Allergan) was evaluated by a dynamic dialysis method.7 (link),22 (link) SCF-EPCS and Film-EPCS were used for this study, and Restasis® was used as control to compare the release profiles of CsA from formulations. Before the release test, proliposomes were dispersed in Milli-Q water, and total CsA content present in the samples was analyzed using HPLC assay. Two microliters of each sample was sealed in dialysis bags (MWCO 14,000 Da; dialysis tubing cellulose membrane, Sigma-Aldrich) by tightening the two ends of the tube by a thin thread. Dialysis tubes were soaked in Milli-Q water 24 hours before use. Then the dialysis bags containing a sample were immersed in a vial containing 10 mL simulated lacrimal fluid (SLF), which was maintained in a water bath at 32°C, based on the temperature of the eye surface, and stirred at a rotating speed of 50 rpm. The composition of SLF was 8.3 g NaCl, 0.084 g CaCl2·2H2O, and 1.4 g KCl in 1 L Milli-Q water.23 (link) At time intervals of 0.5, 1, 2, 3, 4, 5, 6, and 24 hours, 1 mL of samples were withdrawn and immediately replaced with the equal volume of a fresh SLF solution. Withdrawn samples were then centrifuged and CsA contents were analyzed by the HPLC assay.
Restasis
Manufactured by Abbvie
Sourced in United States
Restasis is a prescription eye drop that contains the active ingredient cyclosporine. It is intended to help increase tear production in patients with dry eye disease.
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12 protocols using restasis
1
In Vitro Release of Cyclosporine A from Proliposomes
2
Cyclosporine A Eye Drops and Lenses for Dry Eye
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All procedures, including eye drop administration, applying and removing CLs, and evaluation of tear volume, TBUT, and corneal fluorescein staining were performed under anesthesia with intramuscular ketamine hydrochloride (30 mg/kg) (Yuhan, Seoul, South Korea) and xylazine (6 mg/kg) (Bayer, Leverkusen, Germany) injection [22 (link)]. After 2 weeks of the induction of EDE, the CsA-ED group was treated with 50 µL of 0.05% CsA eye drops (Restasis®, Allergan Inc, Irvine, CA, USA), twice daily. The CL group was treated with naïve soft silicone hydrogel CLs, fabricated with the same mixtures used in fabricating CsA-CLs, only without printing the CsA-loaded CAP matrix solution. They were treated in both eyes, by simply applying the CL on the surface of the rabbit eye and leaving it for 24 h, and replacing the lens daily. The CsA-CL group was treated with a daily exchange of CsA-CLs for 14 days. After 7 and 14 days, clinical parameters including the tear volume, tear film break-up time (TBUT), and corneal fluorescein staining scores were measured. At 14 days after treatment, all rabbits were euthanized for histologic analysis.
3
Topical Therapy for Keratitis Management
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Topical antimicrobial therapy was continued for at least 4 weeks in cases of bacterial keratitis and at least 12 weeks in cases of fungal keratitis. For patients with bacterial keratitis, topical 0.1% dexamethasone (Dexa-Sine SE, Liba, İstanbul, Turkey) or 1% prednisolone (Pred Forte, Allergan, Dublin, Ireland) was initiated at 6 times a day and was tapered to discontinuation at 12 months. For patients with fungal keratitis, 0.5% topical cyclosporine (Restasis, Allergan, Dublin, Ireland) was initiated for the first 2 weeks and if no recurrence of keratitis was observed, 0.1% dexamethasone or 1% prednisolone twice a day was added to the treatment after 2 weeks and was tapered to discontinuation at 12 months. Patients with herpetic keratitis received oral acyclovir (Aklovir, Sandoz, Holzkirchen, Germany) 800 mg 3 times a day for the first 4 weeks postoperatively and continued at a dose of 800 mg for at least 1 year. Artificial tears were prescribed to all patients. Antiglaucoma therapy was initiated if needed. Loose sutures were removed immediately.
4
Dry Eye Disease Treatment Comparison
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All animal experiments have complied with the Association for Research in Vision and Ophthalmology Statement for the Use of Animals in Ophthalmic and Vision Research and the guidelines for Animal Care and Use Committee, Zhejiang University. All animal experiments were approved by the Animal Ethics Committee, the Second Affiliated Hospital, School of Medicine, Zhejiang University (Approval number: 2020–40). Sixty C57BL/6 mice (female, 8 weeks, 20 ± 2 g) were provided by SLAC Laboratory Animal Co., Ltd. The mice were housed in a standard environment with constant temperature (22 ± 1 °C) and a regular light/dark (12 h/12 h) cycle with ad libitum access to food and water. BAK was used to induce experimental DED in mice. Briefly, each right eye of the mice was administered with 5 µL of 0.2% BAK eye drops (w/v) twice per day for 14 consecutive days. Then, the mice were randomly divided into six groups and received topical instillation of 10 µL of 0.9% saline (w/v), Los (15.6 µg kg−1), Tem (2.5 mg kg−1), MTem (Tem: 2.5 mg kg−1), MTem/Los (Tem: 2.5 mg kg−1, Los: 15.6 µg kg−1), and Restasis (Allergan) twice per day, respectively.
5
Topical Anti-Inflammatory Therapy for Dry Eye
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Thirty individuals were prescribed a topical anti-inflammatory therapy, either cyclosporine 0.05% (Restasis, Allergan Inc., Irvine, CA, USA) or lifitegrast 5% (Xiidra, Novartis Pharmaceuticals Corp., East Hanover, NJ, USA) as part of the clinical care. Overall, this group had higher DED symptom severity (DEQ5: 13.97 ± 4.17 vs. 10.94 ± 5.20, p = 0.002) and lower tear production (Schirmer: 10.28 ± 7.16 vs. 13.28 ± 7.33, p = 0.04) compared to individuals not treated with an anti-inflammatory drop. However, the decision to treat was based on the preference of the treating physician. In all patients, a topical corticosteroid was prescribed twice daily for the first month (fluorometholone ophthalmic suspension, 0.1%). The DED symptom response was subjectively assessed approximately 3 months later. Individuals were sorted into two groups: individuals who characterized their ocular surface symptoms as partially or completely resolved upon starting anti-inflammatory therapy, and those with stable or worsening symptoms.
6
Evaluation of OTX-101 Ophthalmic Solution
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The test agent, OTX-101—an aqueous solution at concentrations of 0.01%, 0.05%, or 0.1%—was evaluated in this study. These concentrations correspond to an equivalent dose of 3.5, 17.5, and 35 μg of CsA in a 35 μL instillation, respectively. The comparator, CsA ophthalmic emulsion 0.05%, was obtained from commercially available supplies (Restasis; Allergan, Irvine, CA). The CsA ophthalmic emulsion was removed from the commercial container and placed into sterile glass vials to facilitate dispensing using a calibrated pipette. A new pipette tip was used for each administration of both study drugs. The OTX-101 formulations were analyzed by the manufacturer before shipment and a certificate of analysis was provided for each formulation used. Samples of the OTX-101 formulation were analyzed at the end of the study to confirm CsA stability during the study conduct.
7
Dry Eye Clinical Assessment Protocol
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The subject selection process ensured that no subjects with underlying factors that could affect the conduct of the study or compromise subject safety enrolled in the study. All 91 subjects enrolled had clinical signs of mild to moderate dry eye for at least 6 months prior to study entry. The mean age of subjects was 62 years [standard deviation (SD) 10.68]; 24 subjects were men and 67 were women. Key inclusion criteria at Visits 1 and 2 included a corneal fluorescein staining score of ≥2 in at least one region pre-CAE, a total lissamine green conjunctival score of ≥2 pre-CAE, a Schirmer’s test score of ≤10 and ≥1 mm, a score of ≥2 in at least one symptom pre-CAE, and a demonstrated response to the CAE, based on Ora Calibra™ scales (Ora, Inc., Andover, MA, USA) as discussed in this article.
All subjects had to have demonstrated a reproducible dry eye response to the CAE at Visits 1 and 2. Exclusion criteria included no recent history of ocular surgery/procedures, no clinically significant (CS) slit lamp findings, no ongoing ocular infection or inflammation, no Restasis® (Allergan, Inc., Irvine, CA, USA) use within 30 days of Visit 1 (Day −7), no punctal plug use that was not stable within 30 days of Visit 1, no contact lens use within 7 days of Visit 1, and no use of medications known to cause ocular drying within 30 days of Visit 1.
All subjects had to have demonstrated a reproducible dry eye response to the CAE at Visits 1 and 2. Exclusion criteria included no recent history of ocular surgery/procedures, no clinically significant (CS) slit lamp findings, no ongoing ocular infection or inflammation, no Restasis® (Allergan, Inc., Irvine, CA, USA) use within 30 days of Visit 1 (Day −7), no punctal plug use that was not stable within 30 days of Visit 1, no contact lens use within 7 days of Visit 1, and no use of medications known to cause ocular drying within 30 days of Visit 1.
8
Demographic and Therapy Factors in Dry Eye
9
Dry Eye Treatment with PEG/PG + HP-Guar
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After the study was explained and consent given, eligibility criteria were assessed to ensure all patients had dry eye signs and symptoms. After baseline screening and baseline impression cytology, all 19 patients were instructed to discontinue other artificial tear products but could continue use of Restasis® (cyclosporine A; Allergan, Inc., Irvine, CA, USA) if they had been using it for at least 6 months, because baseline readings may change significantly if chronic usage was discontinued. They were given PEG/PG + HP-Guar, to be used four times per day to both eyes for 1 month. At the end of 1 month, clinical assessments were performed to compare before and after treatment. Samples taken by impression cytology were analyzed by a masked examiner, using flow cytometry. Inflammatory markers (percent cells highly expressing HLA-DR) before and after study treatment were determined.
10
Moxifloxacin, Loteprednol, and Cyclosporine in Ocular Surface Regeneration
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Patients were treated daily with a combination of preservative-free drops of moxifloxacin (0.5%) (Vigamox®, Alcon, USA), 1% loteprednol etabonate (Lotemax®, Bausch &Lomb, U.K) and artificial tears. Moxifloxacin was stopped 10 days after the surgery and loteprednol was tapered slowly in 3 months according to the severity of ocular surface inflammation. Once the overlaying hAM waned away cyclosporine eye drops (Restasis®, Allergan, USA) were added to reduce the risk of dry eye-related inflammation. Topical artificial tear and cyclosporine treatment were continued for the duration of the study. Donor and recipient eyes were examined after 1, 3, 5, 7, 14 and 30 days and 2, 3, 6 and 12 months. Extra visits were performed in case of clinical need. Bio-microscopic anterior segment photographs were taken at each visit. The parametric test values described below were collected Preop and at the 1, 3, 6 and 12-month Postop visits.
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