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Clinical Ophthalmology (Auckland, N.Z.) 2015Symptom relief for the duration of 24 hours after treatment would benefit patients with allergic conjunctivitis.
BACKGROUND
Symptom relief for the duration of 24 hours after treatment would benefit patients with allergic conjunctivitis.
OBJECTIVE
To compare the safety and efficacy of olopatadine 0.77% with vehicle or olopatadine 0.2% in patients with allergic conjunctivitis in a conjunctival allergen-challenge clinical study.
PATIENTS AND METHODS
In this Phase III, multicenter, double-masked, parallel-group, randomized trial, patients with allergic conjunctivitis received olopatadine 0.77%, its vehicle, or olopatadine 0.2%, administered once at visits 3A (day 0), 4A (day 14 ±2), and 5 (day 21 +3). Allergic conjunctivitis-associated sign and symptom assessments included ocular itching, conjunctival redness, total redness, chemosis, and tearing scores. Adverse events and ocular safety parameters were also assessed.
RESULTS
A total of 202 qualifying patients were randomized. Olopatadine 0.77% was superior (P<0.001) to vehicle for treatment of ocular itching at 3, 5, and 7 minutes postchallenge at onset of action and 16- and 24-hour duration of action. Conjunctival redness mean scores were significantly lower for olopatadine 0.77% versus vehicle at all three post-conjunctival allergen-challenge time points: onset (-1.52 to -1.48; P<0.001), 16 hours (-1.50 to -1.38; P<0.01), and 24 hours (-1.58 to -1.38; P<0.05). At 24 hours, olopatadine 0.77% was superior to olopatadine 0.2% at all three postchallenge time points for ocular itching (P<0.05), conjunctival redness (P<0.05), and total redness (P<0.05). No clinically relevant differences in safety parameters or adverse events were observed between the treatment groups.
CONCLUSION
Olopatadine 0.77% is superior to both its vehicle and olopatadine 0.2% for the treatment of allergen-mediated ocular itching and conjunctival redness. Ocular itching symptom relief is maintained over 24 hours, supporting once-daily dosing and demonstrating a comparable safety profile to olopatadine 0.2%.
PubMed: 26392751
DOI: 10.2147/OPTH.S83263 -
Annals of Allergy, Asthma & Immunology... Feb 2020GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).
OBJECTIVE
To evaluate efficacy and safety of GSP301 in patients with seasonal AR (SAR).
METHODS
In this phase 2, double-blind, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665 μg and mometasone 25 μg), once-daily GSP301 (olopatadine 665 μg and mometasone 50 μg), twice-daily or once-daily olopatadine monotherapy (665 μg), mometasone monotherapy (twice-daily 25 μg or once-daily 50 μg), or placebo for 14 days. The primary endpoint-mean change from baseline in morning and evening reflective Total Nasal Symptom Score (rTNSS)-was analyzed using analysis of covariance (ANCOVA; P < .05 = statistically significant). Average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs) were also assessed.
RESULTS
A total of 1111 patients were randomized. Twice-daily GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (P < .001), twice-daily olopatadine (P = .049), and mometasone (P = .004). Similar significant improvements in iTNSS were observed with twice-daily GSP301 vs placebo (P < .001) and twice-daily mometasone (P = .007); improvements were not significant vs olopatadine (P = .058). Once-daily GSP301 provided significant rTNSS and iTNSS improvements vs placebo and once-daily olopatadine (P < .01, all) but improvements were not significant vs mometasone. Treatment-emergent AEs rates were 10.8%, 9.5%, and 8.2%, with twice-daily GSP301, once-daily GSP301, and placebo, respectively.
CONCLUSION
Twice-daily GSP301 treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements in rTNSS (primary endpoint) vs placebo and both monotherapies.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier NCT02318303.
Topics: Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal; Treatment Outcome
PubMed: 31734334
DOI: 10.1016/j.anai.2019.11.007 -
Scientific Reports Oct 2023Ophthalmic preparations that contain ketorolac tromethamine (KET) and olopatadine HCl (OLO) are used to relieve seasonal allergies and allergic conjunctivitis....
UV spectrophotometric methods for simultaneous determination of ketorolac tromethamine and olopatadine hydrochloride: Application of multiple standard addition for assay of ophthalmic solution.
Ophthalmic preparations that contain ketorolac tromethamine (KET) and olopatadine HCl (OLO) are used to relieve seasonal allergies and allergic conjunctivitis. Simultaneous quantification of KET and OLO was held by validated and simple spectrophotometric methods. KET was determined directly from the fundamental UV absorption spectra (at 323 nm), while OLO was determined after performing either dual wavelength or ratio derivative methods. The first method was based on measuring the absorbance difference (ΔA) between 243 and 291 nm, while the second depended on generating first derivative ratio spectra using 3.0 µg/mL KET as a divisor and measuring OLO responses at 234 nm (minima). Multiple standard addition method was applied to enable the determination of OLO which is considered as the weakly absorbing species as well as the minor component in a challenging dosage form ratio (4:1). The linearity ranges of the developed methods were 3-12 μg/mL and 4-40 μg/mL for KET and OLO, respectively. Simultaneous determination of both drugs was successfully implemented to lab prepared eye drops that contain KET, OLO and benzalkonium chloride as an inactive ingredient. Greenness assessment indicates minimal impact on environment. The developed methods determined the cited drugs with % recovery ± SD of 99.63 ± 0.01 for KET, 100.90 ± 0.02 and 100.31 ± 0.01 for OLO using dual wavelength and first derivative ratio methods, respectively. Using F-test and t-test at confidence level %95 to compare between the results of the presented methods and a reported method show no significant difference which allows precise, accurate, rapid, and simple quantification of quality control samples that contain KET and OLO.
Topics: Humans; Olopatadine Hydrochloride; Ketorolac Tromethamine; Ophthalmic Solutions; Conjunctivitis, Allergic; Spectrophotometry
PubMed: 37875539
DOI: 10.1038/s41598-023-45378-8 -
BMC Chemistry Feb 2024Four sensitive and fast analytical approaches relied on ion pairing with eosin Y were built up and evaluated using spectroscopy for determination of Alcaftadine and...
Determination of antihistaminic drugs alcaftadine and olopatadine hydrochloride via ion-pairing with eosin Y as a spectrofluorimetric and spectrophotometric probe: application to dosage forms.
Four sensitive and fast analytical approaches relied on ion pairing with eosin Y were built up and evaluated using spectroscopy for determination of Alcaftadine and Olopatadine hydrochloride with high sensitivity and selectivity. Two spectrofluorimetric techniques were employed to observe the quenching effect of Alcaftadine or Olopatadine hydrochloride on the intrinsic fluorescence of eosin Y in a 0.1 M acetate buffer solution at pH 3.8 and 3.3 for Alcaftadine and Olopatadine hydrochloride, respectively. Those methods are considered the first spectrofluorimetric methods for Alcaftadine and Olopatadine hydrochloride assay. The fluorescence quenching effect was linear with concentration ranging from 150 to 2000 and 200 to 2000 ng mL for Alcaftadine and Olopatadine hydrochloride, respectively. In the two spectrophotometric techniques, the absorbance of the produced ion-pair was monitored at 548 and 547 nm in aqueous buffered solution at pH 3.8 and 3.3 for Alcaftadine and Olopatadine hydrochloride, respectively. Beer's law was obeyed in the concentrations range of 0.8-8.0 and 1.0-10.0 µg mL. The four techniques were evaluated in accordance with ICH requirements and were effectively used to analyze dosage forms with a high percent recovery.
PubMed: 38388420
DOI: 10.1186/s13065-024-01137-y -
Otolaryngologia Polska = the Polish... Dec 2023A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two...
A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines.
Topics: Humans; Mometasone Furoate; Olopatadine Hydrochloride; Administration, Intranasal; Sinusitis; Female; Male; Adult; Anti-Allergic Agents; Drug Combinations; Middle Aged; Treatment Outcome; Rhinitis, Allergic; Rhinitis; Rhinosinusitis
PubMed: 38706259
DOI: 10.5604/01.3001.0054.0941 -
Clinical Ophthalmology (Auckland, N.Z.) 2017Two individual phase 3 conjunctival allergen challenge (CAC) studies of similar design have assessed the efficacy and safety of olopatadine hydrochloride (HCl) 0.77% for...
PURPOSE
Two individual phase 3 conjunctival allergen challenge (CAC) studies of similar design have assessed the efficacy and safety of olopatadine hydrochloride (HCl) 0.77% for the treatment of allergic conjunctivitis. The purpose of this study is to evaluate the integrated efficacy and safety of olopatadine HCl 0.77% from a larger dataset by pooling data from the two individual CAC studies.
METHODS
Data were pooled from two phase 3, randomized, multicenter, double-masked, active- and vehicle-controlled CAC studies. The primary comparison was on ocular itching scores between olopatadine HCl 0.77% versus vehicle (at onset and 24 hours) and olopatadine HCl 0.77% versus olopatadine 0.2% (at 24 hours). Additional end points included conjunctival redness, total redness, and proportion of itching responders at onset and 24-hour duration of CAC. For both primary and secondary analysis, mixed model repeated measures analysis was used, except for proportion of ocular itching responders. Sensitivity analyses were carried out using a two-sample -test.
RESULTS
This analysis included 448 patients. Olopatadine HCl 0.77% was superior to vehicle (<0.0001) at onset and 24-hour duration of action (difference in means: -1.14 to -1.52) and to olopatadine 0.2% (=0.0009) at 24-hour duration of action in relieving ocular itch. Additionally, olopatadine HCl 0.77% substantially reduced conjunctival redness and total redness over vehicle and olopatadine 0.2% at onset and 24-hour duration of action. At 24 hours CAC, there were a higher proportion of itching responders with olopatadine HCl 0.77% compared to vehicle or olopatadine 0.2% (difference in proportion of responders: 43.17%, <0.0001, and 17.25%, =0.0012, respectively). No safety concerns were identified.
CONCLUSION
This analysis confirms the findings from the individual studies. The rapid onset and prolonged duration of action (for 24 hours) of olopatadine HCl 0.77% supports once-daily dosing in the treatment of allergic conjunctivitis.
PubMed: 28652694
DOI: 10.2147/OPTH.S131830 -
Journal of Ophthalmic & Vision Research 2018Allergic conjunctivitis (AC) is associated with itching, redness, tearing, pain, and burning sensation in the eyes. The inflammatory process is caused by the mechanism...
PURPOSE
Allergic conjunctivitis (AC) is associated with itching, redness, tearing, pain, and burning sensation in the eyes. The inflammatory process is caused by the mechanism of immediate hypersensitivity due to direct contact with the allergen. This process triggers mast cells in the conjunctiva to activate and release mediators. The purpose of this study was to compare topical olopatadine and ketotifen in terms of effectiveness and safety for the management of AC.
METHODS
Patients clinically diagnosed with AC were randomized into two groups of 60 patients each and received either topical olopatadine HCl 0.1% or ketotifen fumarate 0.025%. They were followed up on the 4, 15, and 30 days to evaluate symptoms, signs, and quality of life (QOL) scoring.
RESULTS
There were a total of 120 patients (67 men and 53 women) with a mean age of 36.35 ± 11 years. Compared to baseline, scores of itching, tearing, redness, eyelid swelling, chemosis and papillae addition of all the individual scores mentioned above and QOL scores reduced significantly ( = 0.001) by the 4 and 15 days of olopatadine and ketotifen application. Compared with ketotifen, olopatadine significantly reduced itching, tearing, hyperemia, and total AC scores by the 4 day ( = 0.001) and conjunctival papillae by the 15 day ( = 0.001). Adverse reactions were reported in 10% and 18% of patients treated with olopatadine and ketotifen, respectively.
CONCLUSION
Compared to ketotifen, olopatadine provided quicker relief of symptoms, and improved symptoms of AC and QOL, with fewer side effects.
PubMed: 29719638
DOI: 10.4103/jovr.jovr_85_17 -
Acta Ophthalmologica Scandinavica Aug 2003To compare the therapeutic effects of two ophthalmic solutions (0.1% olopatadine hydrochloride and 0.5% ketorolac tromethamine) with different pharmacological mechanisms... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
PURPOSE
To compare the therapeutic effects of two ophthalmic solutions (0.1% olopatadine hydrochloride and 0.5% ketorolac tromethamine) with different pharmacological mechanisms on the clinical signs and Symptoms of seasonal allergic conjunctivitis (SAC).
METHODS
Forty patients with the signs and symptoms of SAC (i.e. hyperaemia, itching, mucus discharge, tearing) were included in this placebo-controlled, randomized, parallel group, single centre study. In group 1 (20 patients) one eye of each patient was treated with olopatadine and the other with placebo. In group 2 (20 patients) one eye of each patient was treated with ketorolac solution and the other with placebo. The principal signs and symptoms of SAC (hyperaemia and itching) were evaluated at 30 mins and at 2, 7 and 15 days.
RESULTS
In group 1, both parameters improved significantly in eyes treated with olopatadine compared with those receiving placebo at all control examinations (all p < 0.05). Similarly, eyes treated with ketorolac showed significant reductions in signs and symptoms compared with those receiving placebo (all p < 0.05). When the clinical parameters of eyes treated with olopatadine were compared with those treated with ketorolac, the mean score of hyperaemia was found to be lower in the olopatadine group, but the difference was not statistically significant (all p > 0.05). However, the itching score was significantly lower in the olopatadine group from the second day through to the end of the study (p < 0.05).
CONCLUSIONS
Both olopatadine and ketorolac ophthalmic solutions were found to be effective in alleviating the clinical signs and symptoms of SAC compared to placebo. However, olopatadine reduces ocular itching significantly more than ketorolac.
Topics: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Conjunctiva; Conjunctivitis, Allergic; Dibenzoxepins; Female; Histamine H1 Antagonists; Humans; Hyperemia; Ketorolac Tromethamine; Male; Olopatadine Hydrochloride; Ophthalmic Solutions; Therapeutic Equivalency
PubMed: 12859265
DOI: 10.1034/j.1600-0420.2003.00079.x -
Clinical Ophthalmology (Auckland, N.Z.) 2023To study the efficacy and toxic effects of bepotastine besilate 1.5% preservative-free (BB-PF) and olopatadine 0.2% BAK-preserved (OL-BAK) drops on the ocular surface of... (Clinical Trial)
Clinical Trial
Efficacy and Toxicity Evaluation of Bepotastine Besilate 1.5% Preservative-Free Eye Drops Vs Olopatadine Hydrochloride 0.2% Bak-Preserved Eye Drops in Patients with Allergic Conjunctivitis.
PURPOSE
To study the efficacy and toxic effects of bepotastine besilate 1.5% preservative-free (BB-PF) and olopatadine 0.2% BAK-preserved (OL-BAK) drops on the ocular surface of patients with allergic conjunctivitis.
PATIENTS AND METHODS
Ninety-seven patients with allergic conjunctivitis diagnosis participated in a prospective, multicenter, randomized, double-blind, controlled, parallel-group clinical trial. Patients received either BB-PF (n=48) or OL-BAK (n=49), both administered once daily in the morning. The patients were followed for 60 days. Ocular itching was the primary outcome measure. Secondary outcomes included ocular symptoms, signs, and non-ocular symptoms associated with rhinoconjunctivitis. Conjunctival impression cytology (CIC) was performed to evaluate histopathological changes related to the toxic effects of preservatives.
RESULTS
BB-PF treatment was associated with a 1.30 more probability of diminished ocular itching than OL-BAK (odds ratio (OR)=1.30; 95% CI=(0.96-1.7); p=0.086). No statistically significant differences were found between treatments in the resolution of other ocular symptoms or signs, except for tearing, which was superior in the BB-PF (OR=1.37; 95% (1.26-1.47); p<0.0001). BB-PF was superior in terms of the resolution of rhinorrhea (p=0.040) and nasal itching (p=0.037). After 60 days of treatment, the BB-PF group exhibited 2.0 times higher probability of having a lower Nelson scale score compared to the OL-BAK group (OR=2.00; 95% CI=(1.19-3.34); p=0.010).
CONCLUSION
Both medications presented a similar efficacy in terms of the resolution of ocular signs and symptoms associated with ocular conjunctivitis. BB-PF is superior in the resolution of non-ocular symptoms and safer for the ocular surface than OL-BAK.
PubMed: 38026598
DOI: 10.2147/OPTH.S431889 -
Case Reports in Gastroenterology 2016The clinical characteristic of gastrointestinal anisakiasis is severe abdominal pain after eating raw fish. Intestinal anisakiasis is more uncommon than gastric...
The clinical characteristic of gastrointestinal anisakiasis is severe abdominal pain after eating raw fish. Intestinal anisakiasis is more uncommon than gastric anisakiasis. Most patients with intestinal anisakiasis need hospitalization because anisakiasis can cause intestinal obstruction, ileus, peritonitis or intestinal perforation. We report a case of intestinal anisakiasis. A 43-year-old woman presented with symptoms of intermittent abdominal pain 2 days after eating raw fish. Her brother had eaten the same food and had been suffering from gastric anisakiasis. Abdominal ultrasonography in this patient showed localized jejunal wall thickening with dilated lumen of proximal jejunum and ascites. According to the clinical course and examinations, she was diagnosed with intestinal anisakiasis. Administration of prednisolone 5 mg/day and olopatadine hydrochloride 10 mg/day improved her symptoms quickly without hospitalization. Prednisolone was administered for 10 days, and olopatadine hydrochloride was administered for a total of 6 weeks according to ultrasonographic findings. Six months after the treatment, the abdominal ultrasonography demonstrated normal findings. This case demonstrates that ultrasonography was quite useful for the diagnosis and surveillance of intestinal anisakiasis. Furthermore, treatment with corticosteroid and an antiallergic agent could be an option for patients with intestinal anisakiasis.
PubMed: 27403099
DOI: 10.1159/000442971