<?xml version='1.0' encoding='utf-8'?>
<eprints xmlns='http://eprints.org/ep2/data/2.0'>
  <eprint id='https://datacompass.lshtm.ac.uk/id/eprint/4598'>
    <eprintid>4598</eprintid>
    <rev_number>26</rev_number>
    <documents>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17500'>
        <docid>17500</docid>
        <rev_number>2</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96245'>
            <fileid>96245</fileid>
            <datasetid>document</datasetid>
            <objectid>17500</objectid>
            <filename>Appendix1-PIS_consent-East_Africa_2.0.pdf</filename>
            <mime_type>application/pdf</mime_type>
            <hash>8586f701f04366fcd6cb96fc5d6d5859fe1dadc3feef5b99860b5097b97139fd</hash>
            <hash_type>SHA256</hash_type>
            <filesize>1900633</filesize>
            <mtime>2025-03-11 10:57:57</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/1/Appendix1-PIS_consent-East_Africa_2.0.pdf</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>1</pos>
        <placement>1</placement>
        <mime_type>application/pdf</mime_type>
        <format>Text</format>
        <language>en</language>
        <security>public</security>
        <license>cc_public_domain</license>
        <main>Appendix1-PIS_consent-East_Africa_2.0.pdf</main>
        <content>documentation</content>
        <retention_period>indefinite</retention_period>
        <formatdesc>Appendix 1 - Consent Details</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17501'>
        <docid>17501</docid>
        <rev_number>2</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96247'>
            <fileid>96247</fileid>
            <datasetid>document</datasetid>
            <objectid>17501</objectid>
            <filename>Appendix2-Monitoring_for_harm.docx</filename>
            <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
            <hash>023b3c6e8524ed839e255eb793675366d04d174b86989b99d927afd6ffd6a043</hash>
            <hash_type>SHA256</hash_type>
            <filesize>17179090</filesize>
            <mtime>2025-03-11 10:58:01</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/2/Appendix2-Monitoring_for_harm.docx</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>2</pos>
        <placement>2</placement>
        <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
        <format>Text</format>
        <language>en</language>
        <security>public</security>
        <license>cc_public_domain</license>
        <main>Appendix2-Monitoring_for_harm.docx</main>
        <content>documentation</content>
        <retention_period>indefinite</retention_period>
        <formatdesc>Appendix 2 - monitoring for harm</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17502'>
        <docid>17502</docid>
        <rev_number>2</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96249'>
            <fileid>96249</fileid>
            <datasetid>document</datasetid>
            <objectid>17502</objectid>
            <filename>Appendix3-Biological_specimens.docx</filename>
            <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
            <hash>02ba0928c2614fb4419c92c2b7612f2065c7c8fb674d1bd6a65873c2c871c5c3</hash>
            <hash_type>SHA256</hash_type>
            <filesize>22788</filesize>
            <mtime>2025-03-11 10:58:03</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/3/Appendix3-Biological_specimens.docx</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>3</pos>
        <placement>3</placement>
        <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
        <format>Text</format>
        <language>en</language>
        <security>public</security>
        <license>cc_public_domain</license>
        <main>Appendix3-Biological_specimens.docx</main>
        <content>documentation</content>
        <retention_period>indefinite</retention_period>
        <formatdesc>Appendix 3 - biological specimens</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17503'>
        <docid>17503</docid>
        <rev_number>2</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96251'>
            <fileid>96251</fileid>
            <datasetid>document</datasetid>
            <objectid>17503</objectid>
            <filename>Appendix4-Spirit_checklist.docx</filename>
            <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
            <hash>13d7a5a520175b2e651fd7c565308661855ed13a7deff9f6712d5a1e41944db8</hash>
            <hash_type>SHA256</hash_type>
            <filesize>30842</filesize>
            <mtime>2025-03-11 10:58:06</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/4/Appendix4-Spirit_checklist.docx</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>4</pos>
        <placement>4</placement>
        <mime_type>application/vnd.openxmlformats-officedocument.wordprocessingml.document</mime_type>
        <format>Text</format>
        <language>en</language>
        <security>public</security>
        <license>cc_public_domain</license>
        <main>Appendix4-Spirit_checklist.docx</main>
        <content>documentation</content>
        <retention_period>indefinite</retention_period>
        <formatdesc>Appendix 4 - Spirit Checklist</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17506'>
        <docid>17506</docid>
        <rev_number>1</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96274'>
            <fileid>96274</fileid>
            <datasetid>document</datasetid>
            <objectid>17506</objectid>
            <filename>indexcodes.txt</filename>
            <mime_type>text/plain</mime_type>
            <hash>d989b8bc9146c35f0af8220b38e042f45505931f663254c6b87e68dff554aa02</hash>
            <hash_type>SHA256</hash_type>
            <filesize>7466</filesize>
            <mtime>2025-03-11 12:08:13</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/5/indexcodes.txt</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>5</pos>
        <placement>5</placement>
        <mime_type>text/plain</mime_type>
        <language>en</language>
        <security>public</security>
        <main>indexcodes.txt</main>
        <relation>
          <item>
            <type>http://eprints.org/relation/isVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17500</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isVolatileVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17500</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isIndexCodesVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17500</uri>
          </item>
        </relation>
        <retention_period>indefinite</retention_period>
        <formatdesc>Generate index codes conversion from Text to indexcodes</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17507'>
        <docid>17507</docid>
        <rev_number>1</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96275'>
            <fileid>96275</fileid>
            <datasetid>document</datasetid>
            <objectid>17507</objectid>
            <filename>indexcodes.txt</filename>
            <mime_type>text/plain</mime_type>
            <hash>5de0d3e89bf2395915c82623b22f0c9f171de60a175fd2f53d2d55bfa34d0ba1</hash>
            <hash_type>SHA256</hash_type>
            <filesize>2781</filesize>
            <mtime>2025-03-11 12:08:13</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/6/indexcodes.txt</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>6</pos>
        <placement>6</placement>
        <mime_type>text/plain</mime_type>
        <language>en</language>
        <security>public</security>
        <main>indexcodes.txt</main>
        <relation>
          <item>
            <type>http://eprints.org/relation/isVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17501</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isVolatileVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17501</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isIndexCodesVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17501</uri>
          </item>
        </relation>
        <retention_period>indefinite</retention_period>
        <formatdesc>Generate index codes conversion from Text to indexcodes</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17508'>
        <docid>17508</docid>
        <rev_number>1</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96276'>
            <fileid>96276</fileid>
            <datasetid>document</datasetid>
            <objectid>17508</objectid>
            <filename>indexcodes.txt</filename>
            <mime_type>text/plain</mime_type>
            <hash>74b7a6897ee5af9f7c063c5605019f2f3bb128b87cb1353fc11f6cf246db99b5</hash>
            <hash_type>SHA256</hash_type>
            <filesize>4524</filesize>
            <mtime>2025-03-11 12:08:13</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/7/indexcodes.txt</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>7</pos>
        <placement>7</placement>
        <mime_type>text/plain</mime_type>
        <language>en</language>
        <security>public</security>
        <main>indexcodes.txt</main>
        <relation>
          <item>
            <type>http://eprints.org/relation/isVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17502</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isVolatileVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17502</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isIndexCodesVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17502</uri>
          </item>
        </relation>
        <retention_period>indefinite</retention_period>
        <formatdesc>Generate index codes conversion from Text to indexcodes</formatdesc>
      </document>
      <document id='https://datacompass.lshtm.ac.uk/id/document/17509'>
        <docid>17509</docid>
        <rev_number>1</rev_number>
        <files>
          <file id='https://datacompass.lshtm.ac.uk/id/file/96277'>
            <fileid>96277</fileid>
            <datasetid>document</datasetid>
            <objectid>17509</objectid>
            <filename>indexcodes.txt</filename>
            <mime_type>text/plain</mime_type>
            <hash>a6738ce5da474c5fa1e3efc11b9724f4727feac7a20a1c2f74abd0059ccd919e</hash>
            <hash_type>SHA256</hash_type>
            <filesize>4276</filesize>
            <mtime>2025-03-11 12:08:13</mtime>
            <url>https://datacompass.lshtm.ac.uk/id/eprint/4598/8/indexcodes.txt</url>
          </file>
        </files>
        <eprintid>4598</eprintid>
        <pos>8</pos>
        <placement>8</placement>
        <mime_type>text/plain</mime_type>
        <language>en</language>
        <security>public</security>
        <main>indexcodes.txt</main>
        <relation>
          <item>
            <type>http://eprints.org/relation/isVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17503</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isVolatileVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17503</uri>
          </item>
          <item>
            <type>http://eprints.org/relation/isIndexCodesVersionOf</type>
            <uri>https://datacompass.lshtm.ac.uk/id/document/17503</uri>
          </item>
        </relation>
        <retention_period>indefinite</retention_period>
        <formatdesc>Generate index codes conversion from Text to indexcodes</formatdesc>
      </document>
    </documents>
    <eprint_status>archive</eprint_status>
    <userid>540</userid>
    <dir>disk0/00/00/45/98</dir>
    <datestamp>2025-03-11 11:00:06</datestamp>
    <lastmod>2025-08-28 08:41:26</lastmod>
    <status_changed>2025-03-11 11:00:06</status_changed>
    <type>data_collection</type>
    <metadata_visibility>show</metadata_visibility>
    <creators>
      <item>
        <name>
          <family>Hoffman</family>
          <given>Jeremy</given>
        </name>
        <orcid>0000-0001-9454-2131</orcid>
        <lshtm_flag>TRUE</lshtm_flag>
        <staffid>19cac4985abfc442e2ba2334bb3b2190</staffid>
      </item>
    </creators>
    <corp_creators>
      <item>London School of Hygiene &amp; Tropical Medicine, London, United Kingdom</item>
    </corp_creators>
    <title>Appendix files for &quot;Randomised controlled trial of topical combination therapy chlorhexidine 0.2% and natamycin 5% versus topical natamycin 5% alone for fungal keratitis in East Africa&quot;</title>
    <divisions>
      <item>ITCR</item>
    </divisions>
    <keywords>
      <item>Fungal keratitis</item>
      <item>natamycin</item>
    </keywords>
    <abstract>This is the first randomised controlled clinical trial comparing natamycin 5% eye drops alone to natamycin 5% and chlorhexidine 0.2% combination eye drops for the treatment of fungal keratitis, an infection to the front of the eye that can lead to blindness if not treated appropriately. This page contains appendix files associated with the trial.</abstract>
    <date>2025-03-06</date>
    <date_type>completed</date_type>
    <publisher>London School of Hygiene &amp; Tropical Medicine</publisher>
    <id_number>10.17037/DATA.00004598</id_number>
    <data_type>Other</data_type>
    <copyright_holders>
      <item>London School of Hygiene &amp; Tropical Medicine, London, United Kingdom</item>
    </copyright_holders>
    <research_centre>
      <item>XICH</item>
    </research_centre>
    <collection_mode>
      <item>Other</item>
    </collection_mode>
    <primary_contact>
      <name>
        <family>Hoffman</family>
        <given>Jeremy</given>
      </name>
      <email>Jeremy.Hoffman@lshtm.ac.uk</email>
      <orcid>0000-0001-9454-2131</orcid>
      <lshtm_flag>FALSE</lshtm_flag>
      <staffid>19cac4985abfc442e2ba2334bb3b2190</staffid>
    </primary_contact>
    <study_abstract>This is the first randomised controlled clinical trial comparing natamycin 5% eye drops alone to natamycin 5% and chlorhexidine 0.2% combination eye drops for the treatment of fungal keratitis, an infection to the front of the eye that can lead to blindness if not treated appropriately. In this article we describe how we plan to conduct this clinical trial. The primary analysis will be a comparison by arm of best spectacle corrected visual acuity at 3 months, i.e. how well patients can see with glasses if needed at the end of the study period.</study_abstract>
    <full_text_status>public</full_text_status>
    <place_of_pub>London, United Kingdom</place_of_pub>
    <funders>
      <item>Wellcome Trust</item>
    </funders>
    <projects>
      <item>Randomised controlled trial of topical combination therapy chlorhexidine 0.2% and natamycin 5% versus topical natamycin 5% alone for fungal keratitis in East Africa</item>
    </projects>
    <resourcetype>
      <resourcetypegeneral>Other</resourcetypegeneral>
      <resourcetype>SPIRIT Checklist</resourcetype>
    </resourcetype>
    <grant>207472/Z/17/Z</grant>
    <geographic_cover>Tanzania, Uganda</geographic_cover>
    <language>
      <item>en</item>
    </language>
    <repo_link>
      <item>
        <title>Randomised controlled trial of topical combination therapy chlorhexidine 0.2% and natamycin 5% versus topical natamycin 5% alone for fungal keratitis in East Africa: study protocol [version 1; peer review: 2 approved]</title>
        <link>https://researchonline.lshtm.ac.uk/id/eprint/4677301</link>
      </item>
    </repo_link>
    <funders_info>
      <item>
        <project>Randomised controlled trial of topical combination therapy chlorhexidine 0.2% and natamycin 5% versus topical natamycin 5% alone for fungal keratitis in East Africa</project>
        <funder_name>Wellcome Trust</funder_name>
        <grant>207472/Z/17/Z</grant>
        <funder_id>http://dx.doi.org/10.13039/100010269</funder_id>
      </item>
    </funders_info>
    <project_funders_info>
      <item>
        <funder_name>Wellcome Trust</funder_name>
        <grant>207472/Z/17/Z</grant>
        <funder_id>http://dx.doi.org/10.13039/100010269</funder_id>
      </item>
    </project_funders_info>
    <ukri_date_sub>2025-03-06</ukri_date_sub>
  </eprint>
</eprints>
