(PO-132)COLLABORATIVE ASSESSMENT OF MYOPIA PROGRESSION WITH PIRENZEPINE (CAMPP) STUDY: RECRUITMENT UNDERWAY FOR FDA (PIR-205) CLINICAL TRIAL

Myopia is a major cause of visual impairment. Its prevalence is growing steadily, especially in East Asia. Despite the immense disease and economic burden, there are currently no Food and Drug Administration-approved drugs for myopia. This review aims to summarise pharmaceutical interventions of myopia at clinical and preclinical stages in the last decade and discuss challenges for preclinical myopia drugs to progress to clinical trials. Atropine and oral 7-methylxanthine are shown to reduce myopia progression in human studies. The former has been extensively studied and is arguably the most successful medication. However, it has side effects and trials on low-dose atropine are ongoing. Other pharmaceutical agents being investigated at a clinical trial level include ketorolac tromethamine, oral riboflavin and BHVI2 (an experimental drug). Since the pathophysiology of myopia is not fully elucidated, numerous drugs have been tested at the preclinical stage and can be broadly categorised based on the proposed mechanisms of myopisation, namely antimuscarinic, dopaminergic, anti-inflammatory and more. However, several agents were injected intravitreally or subconjunctivally, hindering their progress to human trials. Furthermore, with atropine being the most successful medication available, future preclinical interventions should be studied in combination with atropine to optimise the treatment of myopia.

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Baseline Characteristics in the Myopia Progression Study, a Clinical Trial of Bifocals to Slow Myopia Progression

Optometry and Vision Science ◽

10.1097/00006324-199807000-00016 ◽

1998 ◽

Vol 75 (7) ◽

pp. 485-492 ◽

Cited By ~ 11

Author(s):

GEORGE W. FULK ◽

LYNN A. CYERT ◽

DONALD E. PARKER

Keyword(s):

Clinical Trial ◽

Myopia Progression ◽

Baseline Characteristics

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Rate of patient’s Recruitment and Recruitment Derivatives from the Perspectives of Internal factors - Protocol Study Nosology, Experience of Investigators and Potential Patient’s Pool of Sites

10.54026/cjct/1007 ◽

2021 ◽

Vol 2 (2) ◽

pp. 1-6

Author(s):

Svyatoslav Milovanov

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Statistical Analysis ◽

Retrospective Analysis ◽

Analysis Data ◽

Recruitment Rate ◽

Internal Factor ◽

Internal Factors ◽

Study Recruitment ◽

Protocol Study

The recruitment as a process found by many authors to be undergoing of many factors. There is a factors which are decreasing the recruitment and last data is reporting up to 80% trials failed due to law or even absence of recruitment on level of sites. But the factors are differently changing the recruitment. The final number of recruitment is static figure very well known, there is also known speed of recruitment which is calculating in the start of the study and these parameters along with others is quantitative evaluation of recruitment. We investigated the rate of recruitment in the light of some factors using parameters reflecting the recruitment progress of recruitment. Materials and Methods: Retrospective analysis of data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years. Study objectives: to investigate the study recruitment rate using different parameters and its changes along with acting of internal factors; to develop new parameters which could be sensitive for evaluation of factor’s action. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was determined rate of recruitment and its derivatives where was acting an internal factor. Discussion: Recruitment been undergone the internal factors. The way of action is multidirectional and could boost the recruitment and in opposite to decrease one and knowing it is important in success of recruitment and clinical trial itself eventually

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Dietary Supplement Crocetin Has a Suppressive Effect Against Myopia Progression: A Randomized Clinical Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3384857 ◽

2019 ◽

Author(s):

Kiwako Mori ◽

Hidemasa Torii ◽

Satoko Fujimoto ◽

Xiaoyan Jiang ◽

Shin-ichi Ikeda ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Dietary Supplement ◽

Suppressive Effect ◽

Myopia Progression

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The Effect of Dietary Supplementation of Crocetin for Myopia Control in Children: A Randomized Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm8081179 ◽

2019 ◽

Vol 8 (8) ◽

pp. 1179 ◽

Cited By ~ 1

Author(s):

Kiwako Mori ◽

Hidemasa Torii ◽

Satoko Fujimoto ◽

Xiaoyan Jiang ◽

Shin-ichi Ikeda ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Large Scale ◽

Suppressive Effect ◽

Institutional Review Boards ◽

Controlled Clinical Trial ◽

Myopia Progression ◽

Double Blind ◽

Institutional Review ◽

To Receive

The prevalence of myopia has been increasing in recent years. The natural carotenoid crocetin has been reported to suppress experimental myopia in mice. We evaluated the effects of crocetin on myopia suppression in children. A multicenter randomized double-blind placebo-controlled clinical trial was performed with 69 participants aged 6 to 12 years, whose cycloplegic spherical equivalent refractions (SER) were between −1.5 and −4.5 diopter (D). The participants were randomized to receive either a placebo or crocetin and followed up for 24 weeks. Axial length (AL) elongation and changes in SER were evaluated for 24 weeks. Both written informed assent from the participants and written informed consent from legal guardians were obtained in this study because the selection criteria of this trial included children aged between 6 and 12 years old. This trial was approved by the institutional review boards. A mixed-effects model was used for analysis, using both eyes. Two participants dropped out and 67 children completed this trial. The change in SER in the placebo group, −0.41 ± 0.05 D (mean ± standard deviation), was significantly more myopic compared to that in the crocetin group, −0.33 ± 0.05 D (p = 0.049). The AL elongation in the placebo group, 0.21 ± 0.02 mm, was significantly bigger than that in the crocetin group, 0.18 ± 0.02 mm (p = 0.046). In conclusion, dietary crocetin may have a suppressive effect on myopia progression in children, but large-scale studies are required in order to confirm this effect.

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A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality vs. Enhanced Care as Usual for Suicidal Soldiers

10.21236/ada562326 ◽

2012 ◽

Author(s):

David A. Jobes ◽

Katherine Comtois ◽

Peter Gutierrez ◽

Lisa Brenner ◽

Bruce Crow ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Collaborative Assessment

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Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

BMC Ophthalmology ◽

10.1186/s12886-021-01865-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Daniela Lopes-Ferreira ◽

Alicia Ruiz-Pomeda ◽

Belén Peréz-Sanchéz ◽

António Queirós ◽

César Villa-Collar

Keyword(s):

Clinical Trial ◽

Contact Lenses ◽

Spherical Aberration ◽

High Order ◽

Control Group ◽

Myopia Progression ◽

Corneal Aberrations ◽

Single Vision ◽

Control Versus ◽

Low Order

Abstract Background To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period. Methods Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed. Results Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05). Conclusions Along 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time. Trial registration : ClinicalTrials.gov Identifier: NCT01917110.

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