Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension

Tokio Obata; Saori Deguchi; Jyoji Yoshitomi; Kazunori Inaba; Yoko Urashima; Takuro Kobori; Kouichi Hosomi; Noriaki Nagai; Yuichiro Nakada

doi:10.1371/journal.pone.0277311

Peer Review History

Original SubmissionJuly 8, 2022
26 Sep 2022 Decision Letter - Ajaya Bhattarai, Editor PONE-D-22-18883Effect of Storage Temperature on the Dispersibility of commercially available 0.1% Fluorometholone Ophthalmic SuspensionPLOS ONE Dear Dr. Nakada, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== ACADEMIC EDITOR: Two reviewers suggested for major revision and one reviewer suggested minor revision. ============================== Please submit your revised manuscript by Nov 05 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: No Reviewer #3: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This manuscript describes the dispersion behaviors of three fluorometholone ophthalmic suspension eye drops (one original drug and two generic drugs) of 0.1% at different temperatures. My opinions and comments about this manuscript are as follows: 1) In all manuscript, section numbers should be checked. The use of section numbers in only subsections is inappropriate. 2) Lines 91-93, etc.: In all manuscript and in references, the use of capital letters should be checked. 3) Line 111: “Further,” should be replaced by “Furthermore,”. 4) Lines 120, 131, 146-147, etc.: In all manuscript, there is no coherence in the use of capital and small letters during the spelling of subsection titles. 5) Lines 162, 164, 165, 170, etc.: In all manuscript, please use subscript for “s” in “Vs”, for “p” in “Dp”, for “g” in “ρg” and for “f” in “ρf”. 6) Lines 218, 251, etc.: In all manuscript, please use small letters in the spelling of “Low” and “Room”. 7) Lines 222-223; 255-256; 275-278; 300-301; etc.: The place of these statements is inappropriate!!! They should be given in figure captions, not in text. 8) Line 418: Please add a “Conclusion” section. 9) Line 419: “Reference” should be replaced by “References”. 10) Lines 419-492: This section should be checked according to the reference format of plos One. 11) Figure captions should be presented before figures. 12) Fig. 3: The quality of Fig. 3 should be improved. 13) Fig. 5: • “frequency” should be replaced by “Frequency”. • In x-axes, “Particle Size” should be replaced by “Particle size”. Reviewer #2: The manuscript, although interesting and well-designed and conducted, needs extensive language editing. Some sentences are exceedingly long and difficult to follow. I suggest the authors to omit numbering in the results section and use plain subheading; or alternatively without any subheadings. If subheadings are preferred a similar style may be useful in the Discussion section as well. Reviewer #3: An interesting and relevant topic. It is however a very technical manuscript which is not so easy to read for the clinician. This is partly caused by the often long sentences with significant sub-sentences. I have no questions concerning the content. The research is soundly executed, and is presented and discussed step by step. I do recommend shortening of the often complex and long sentences to increase the readability of this technical manuscript. Furthermore a suggestion to perhaps incorporate advices for the ophthalmic clinician, i.e. apart from the frequency of administration, a storage or use advice may also be discussed. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Eray Atalay Reviewer #3: Yes: H.M. van Minderhout, MSc ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0277311.r001
Revision 1
17 Oct 2022 Author Response Response to Reviewer 1’s Comments We would like to thank #Reviewer 1 for the valuable suggestions on our manuscript. We have carefully read all of your comments and suggestions and have made the corrections in the revised version of the manuscript. Detailed responses to your comments are listed below, and we have highlighted all changes which can be viewed as tracked changes in the file labeled “Revised Manuscript with Track Changes.” We hope that the revised manuscript would be satisfactory for publication in PLoS ONE. Q1. In all manuscript, section numbers should be checked. The use of section numbers in only subsections is inappropriate. A1. According to #Reviewer 1’s comment, we removed the numbering in the Results section (Lines 188–189, 200–201, 223–234). Q2. Lines 91-93, etc.: In all manuscript and in references, the use of capital letters should be checked. A2. The reviewer’s comments are very important. We checked the use of capital letters in this manuscript. The name of products and vendors are not changed, since these are original notation. Thank you for pointing out this (Lines 91–93). Q3. Line 111: “Further,” should be replaced by “Furthermore,”. A3. Thank you very much for pointing this out. We revised to “Furthermore” from “Further” in Materials and Methods (Lines 111). Q4. Lines 120, 131, 146-147, etc.: In all manuscript, there is no coherence in the use of capital and small letters during the spelling of subsection titles. A4. The reviewer’s comment is correct. We unified the use of capital and small letters in the spelling of subsection titles in Materials and Methods and Results. Please refer to the comments in the file labeled “Revised Manuscript with Track Changes” (Lines 103,125,140,149,172,181,188-189). Q5. Lines 162, 164, 165, 170, etc.: In all manuscript, please use subscript for “s” in “Vs”, for “p” in “Dp”, for “g” in “ρg” and for “f” in “ρf”. A5. Thank you for pointing out this. We have incorporated subscript “s”, “p”, “g”, and “f” into Stokes’ equation (Lines 32–33, 155, 157-158, 163, 228–229, Table 2). Q6. Lines 218, 251, etc.: In all manuscript, please use small letters in the spelling of “Low” and “Room”. A6. In order to respond to the reviewer’s comment, we replaced “Low” and “Room” with “low” and “room” throughout the manuscript. Please refer to the comments in the file labeled “Revised Manuscript with Track Changes” (Lines 446, 455, 464, 474). Q7. Lines 222-223; 255-256; 275-278; 300-301; etc.: The place of these statements is inappropriate!!! They should be given in figure captions, not in text. A7. The reviewer’s comments are very important. In order to respond to the reviewer’s comment, we moved all Figure Captions after the References (Lines 429–488). Q8. Line 418: Please add a “Conclusion” section. A8. Thank you for pointing out this. We added the Conclusion section (Lines 345–359). Q9. Line 419: “Reference” should be replaced by “References”. A9. According to #Reviewer 1’s comment, we corrected to “ References” (Line 361). Q10. Lines 419-492: This section should be checked according to the reference format of plos One. A10. The reviewer’s comment is correct. We revised the reference format according to the submission guidelines of PLoS ONE (References, Lines 361–426). Q11. Figure captions should be presented before figures. A11. Thank you very much for pointing this out. In order to respond to the reviewer’s comment, we moved all Figure Captions after the References (Lines 429–488). Q12. Fig. 3: The quality of Fig. 3 should be improved. A12. In order to respond to the reviewer’s comment, we improved the quality of Figure 3 (Figure 3). Q13. Fig. 5:• “frequency” should be replaced by “Frequency”. • In x-axes, “Particle Size” should be replaced by “Particle size”. A13. The reviewer’s comment is correct. We revised “frequency” to “Frequency”, and “Particle Size” to “Particle size” in Figure 5 (Figure 5). Thank you for great comments. Response to Reviewer 2’s Comments We would like to thank #Reviewer 2 for the valuable suggestions on our manuscript. We have carefully read all of your comments and suggestions and have made the corrections in the revised version of the manuscript. Detailed responses to your comments are listed below, and we have highlighted all changes which can be viewed as tracked changes in the file labeled ‘Revised Manuscript with Track Changes’. We hope that the revised manuscript would be satisfactory for publication in PLoS ONE. Q1. The manuscript, although interesting and well-designed and conducted, needs extensive language editing. Some sentences are exceedingly long and difficult to follow. A1. In order to respond to the reviewer’s comment, this manuscript has been re-edited by English editing service Editage (Job code: BCIO_1_3). Q2. I suggest the authors to omit numbering in the results section and use plain subheading; or alternatively without any subheadings. If subheadings are preferred a similar style may be useful in the Discussion section as well. A2. Thank you very much for pointing this out. We removed the numbering in the Results section, and applyied the plain subheadings (Lines 187–234). Thank you for great comments. Response to Reviewer 3’s Comments We would like to thank #Reviewer 3 for the valuable suggestions on our manuscript. We have carefully read all of your comments and suggestions and have made the corrections in the revised version of the manuscript. Detailed responses to your comments are listed below, and we have highlighted all changes which can be viewed as tracked changes in the file labeled ‘Revised Manuscript with Track Changes’. We hope that the revised manuscript would be satisfactory for publication in PLoS ONE. Q1. It is however a very technical manuscript which is not so easy to read for the clinician. This is partly caused by the often long sentences with significant sub-sentences. I have no questions concerning the content. The research is soundly executed, and is presented and discussed step by step. I do recommend shortening of the often complex and long sentences to increase the readability of this technical manuscript. Furthermore a suggestion to perhaps incorporate advices for the ophthalmic clinician, i.e. apart from the frequency of administration, a storage or use advice may also be discussed. A1. According to #Reviewer 3’s comment, this manuscript has been re-edited by English editing service Editage (Job code: BCIO_1_3). We also incorporated the Conclusion section including the recommendations for ophthalmic clinicians and pharmacists (Lines 345–359). Thank you for great comments. Attachments Attachment Submitted filename: Response_to_Reviewers_TO_final20221018.docx https://doi.org/10.1371/journal.pone.0277311.r002
25 Oct 2022 Decision Letter - Ajaya Bhattarai, Editor Effect of Storage Temperature on the Dispersibility of Commercially Available 0.1% Fluorometholone Ophthalmic Suspension PONE-D-22-18883R1 Dear Dr. Nakada Yuichiro, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Ajaya Bhattarai Academic Editor PLOS ONE Additional Editor Comments (optional): The academic editor is satisfied with the revised manuscript. Reviewers' comments: https://doi.org/10.1371/journal.pone.0277311.r003
Formally Accepted
27 Oct 2022 Acceptance Letter - Ajaya Bhattarai, Editor PONE-D-22-18883R1 Effect of Storage Temperature on the Dispersibility of Commercially Available 0.1% Fluorometholone Ophthalmic Suspension Dear Dr. Nakada: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Ajaya Bhattarai Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0277311.r004

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