scholarly journals A Randomized, Controlled Study of the Efficacy and Safety of a New Eyedrop Formulation for Moderate to Severe Dry Eye Syndrome

2016 ◽  
Vol 27 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Frédéric Chiambaretta ◽  
Serge Doan ◽  
Marc Labetoulle ◽  
Nicolas Rocher ◽  
Lamia El Fekih ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Dry Eye ◽  
Keratoconjunctivitis Sicca ◽  
Phase Iii ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Conjunctival Hyperemia ◽  
Blurred Vision ◽  
Ocular Symptoms ◽  
Global Performance

Purpose This study compared the efficacy and safety of hyaluronic acid (HA)-trehalose, a new eyedrop containing trehalose (a natural bioprotectant) and HA, to an established formulation containing only HA. Methods This was a phase III, randomized, active-controlled, investigator-masked, multicenter study in France and Tunisia. In all, 105 adult patients (≥18 years) with moderate to severe dry eye disease (DED) received either HA-trehalose (n = 52) or HA (n = 53) 3-6 times per day for 84 days. The primary efficacy variable was the Oxford grading score at day 35. A questionnaire on dry eye and symptoms, Schirmer test, tear break-up time, conjunctival hyperemia, and global performance were assessed as secondary efficacy criteria at baseline, day 35, and day 84. Safety assessments were standard. Results Noninferiority of HA-trehalose to HA for keratoconjunctivitis sicca assessed by Oxford grading score was demonstrated at day 35. For the secondary efficacy parameters, reductions in dry eye questionnaire classes of none or mild at day 84, dry eye symptoms of stinging, itching, and blurred vision at day 35, and investigator (days 35 and 84) and patient assessments (day 35) of global performance were significantly better for HA-trehalose. There were no clinically meaningful differences between groups for the other secondary criteria. Both treatments were well-tolerated, and there were fewer ocular symptoms upon instillation and fewer adverse events for HA-trehalose than for HA. Conclusions Hyaluronic acid-trehalose is effective and safe, with better patient satisfaction, than existing HA-only eyedrops particularly from the first month of treatment, and offers a therapeutic advancement in the treatment of moderate to severe DED.

scholarly journals Recurrent keratoconjunctivitis as the sole manifestation of COVID-19 infection: A case report

2021 ◽  
pp. 112067212110065
Author(s):  
Satria Audi Hutama ◽  
Firas Farisi Alkaff ◽  
Ryan Enast Intan ◽  
Citra Dewi Maharani ◽  
Luki Indriaswati ◽  
...  
Keyword(s):  
Case Report ◽  
Foreign Body ◽  
Foreign Body Sensation ◽  
Polymerase Chain Reaction Test ◽  
Nasopharyngeal Swab ◽  
Conjunctival Hyperemia ◽  
Blurred Vision ◽  
Ocular Symptoms ◽  
Body Sensation ◽  
Fluorescence Test

Introduction: Ocular symptoms are uncommon manifestations of coronavirus disease 2019 (COVID-19) infection. Earlier study reported that dry eye, blurred vision, foreign body sensation, tearing, itching, conjunctival secretion, conjunctival congestion, ocular pain, and photophobia are among the ocular symptoms that could be found in COVID-19 patients. However, there are only a few reports available regarding corneal involvement in this disease. Here we report a case of keratoconjunctivitis as the only symptom of COVID-19 infection. Case description: A 27-year-old man who worked as an obstetrics and gynecology resident came to the outpatient clinic with the chief complaints of eye discomfort, foreign body sensation, conjunctival hyperemia, lacrimation, and photophobia in his right eye for the past 3 weeks. Fluorescence test showed a small corneal lesion. The patient was then diagnosed with keratoconjunctivitis. A week after the treatment, all symptoms were resolved. A month later, the patient came to the emergency room with the same eye complaints but with a more severe pain. The fluorescence test showed wider corneal lesion compared to last month. The result from the corneal swab is negative for bacterial or fungal infection, indicating a viral infection. Afterwards, reverse transcriptase polymerase chain reaction test from nasopharyngeal swab was performed and revealed that the patient was positive for COVID-19. Conclusions: This case report showed that keratoconjunctivitis may occur as the only manifestation of COVID-19 infection. Thus, patient presented with unexplainable eye symptoms should be evaluated for COVID-19 infection.

FRESCO-2: A global phase III study of the efficacy and safety of fruquintinib in patients (pts) with metastatic colorectal cancer (mCRC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS154-TPS154
Author(s):  
Arvind Dasari ◽  
James C. Yao ◽  
Alberto F. Sobrero ◽  
Takayuki Yoshino ◽  
William R. Schelman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Growth Factor ◽  
Phase Iii ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Wild Type ◽  
Phase 3 ◽  
Prior Therapy ◽  
Anti Vegf ◽  
The Us

TPS154 Background: Pts with mCRC have limited treatment options following progression on standard therapies. Current standard of care (SOC) after pts progress on trifluridine/tipiracil (TAS-102) or regorafenib is re-challenge with previous systemic treatments, enrollment in a clinical trial, or best supportive care (BSC). Fruquintinib (Elunate) is a novel, highly selective, vascular endothelial growth factor (VEGF) receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) ( Cancer Biol Ther 2014;15:1635-1645). Fruquintinib is approved in China to treat pts with mCRC who received or are intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-epidermal growth factor receptor (EGFR) therapy. Approval was based on results of the phase 3 FRESCO study (2013-013-00CH1; NCT02314819; JAMA 2018;319:2486-2496), in which fruquintinib 5 mg daily (QD), 3 weeks on, 1 week off (3 on/1 off), significantly improved overall survival (OS) in pts with mCRC in the 3rd-line+ setting when compared to placebo (median OS 9.3 months [mo] versus 6.6 mo; hazard ratio [HR] 0.65; p < .001). Progression-free survival (PFS) was also superior (median PFS 3.7 mo versus 1.8 mo; HR 0.26; p < .001). The toxicities of fruquintinib were consistent with those of other VEGF TKIs and were manageable. At the time FRESCO was conducted in China, SOC for pts with mCRC differed from that in the US, EU, and Japan. We describe here a global phase 3 study (FRESCO-2; 2019-013-GLOB1; NCT04322539) being conducted to investigate fruquintinib’s efficacy and safety in pts with refractory mCRC and a treatment profile representative of the global SOC. Methods: FRESCO-2 is a randomized, double-blind, placebo-controlled study to compare fruquintinib + BSC to placebo + BSC. Key inclusion criteria are progression on or intolerance to treatment with TAS-102 and/or regorafenib; previous treatment with standard approved therapies including chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-EGFR therapy. Prior therapy with immune checkpoint or BRAF inhibitors is required for pts with corresponding tumor alterations. Pts (~522) will be randomized 2:1 to receive either fruquintinib 5 mg orally (PO) QD + BSC or placebo 5 mg PO QD + BSC, with a 3 on/1 off schedule. Randomization will be stratified by prior therapy, RAS status, and duration of metastatic disease. The primary endpoint is OS; secondary endpoints include PFS, disease control rate, objective response rate, duration of response, and safety. Final OS analyses will be performed when 364 OS events are observed; futility analysis will be conducted with 1/3 (121) OS events. If enrichment of post-regorafenib pts occurs, enrollment to that strata will be capped at approximately 262. FRESCO-2 will be activated in the US, EU, and Japan; global enrollment is anticipated over 13 mo. Clinical trial information: NCT04322539.

scholarly journals Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study

2018 ◽  
Vol Volume 12 ◽  
pp. 2499-2508 ◽  
Author(s):  
Marc Labetoulle ◽  
Stefanie Schmickler ◽  
David Galarreta ◽  
Daniel Boehringer ◽  
Abayomi Ogundele ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Clinical Study ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Hydroxypropyl Guar

Efficacy and Safety of a Cationic Emulsion in the Treatment of Moderate to Severe Dry Eye Disease: A Randomized Controlled Study

2016 ◽  
Vol 26 (6) ◽  
pp. 546-555 ◽  
Author(s):  
Pierre-Yves Robert ◽  
Béatrice Cochener ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sébastien Garrigue ◽  
...  
Keyword(s):  
Dry Eye ◽  
Dry Eye Disease ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Randomized Controlled

scholarly journals Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
Cheng Hong ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Treatment Group ◽  
Phase Iii ◽  
World Health ◽  
Controlled Study ◽  
Stable Phase ◽  
Control Group ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Health Organization

Abstract Background Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH. Methods/design A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded. Discussion We aimed to determine the efficacy and safety of TMP for the treatment of PH. Trial registration Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.

Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16099-e16099
Author(s):  
S. Oudard ◽  
T. Eisen ◽  
C. Szczylik ◽  
M. Siebels ◽  
S. Negrier ◽  
...  
Keyword(s):  
Clear Cell ◽  
Formal Analysis ◽  
Phase Iii ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Cell Renal Cell Carcinoma ◽  
Double Blind ◽  
Diabetes Status ◽  
Study Population ◽  
Clear Cell Rcc

e16099 Background: Results of the phase III TARGET trial, a randomized, double-blind, placebo-controlled study of sorafenib (SOR) treatment in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective and safe for pts with advanced RCC, leading to the approval of SOR for the treatment of advanced RCC. Diabetes can be associated with increased morbidity during treatment in a variety of malignancies. Therefore, an exploratory subset analysis was performed to evaluate the efficacy and safety of SOR in pts enrolled in TARGET with or without diabetes at baseline. Methods: Pts (N=903) with advanced clear-cell RCC, ECOG PS 0–2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or placebo (PBO). End points included OS, PFS, and safety. A planned independently-assessed formal analysis of PFS showed significant benefit for SOR over PBO; consequently, pts assigned to PBO were able to cross over to SOR. Results: Pt demographics were similar for all subsets. Pre- crossover data by subset are shown in the table . The incidence of drug-related adverse events (AEs) across subgroups was consistent with that for the overall population. In pts with vs without diabetes, treatment with SOR was not associated with increased hyperglycemia (1 pt/arm in the without diabetes subgroups only) or hypertension. Conclusions: The safety profile of SOR in pts with diabetes was comparable with that for the overall study population. SOR was well tolerated and AEs were manageable. Trends in improved PFS were observed for SOR regardless of baseline diabetes status; however, the small diabetic subset limits interpretation of a SOR OS benefit in this subpopulation. *Final PFS of overall study population based on independent review from Jan 2005; all other data from May 2005 database [Table: see text] [Table: see text]

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