Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508721722676 Date of Registration: 01/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mask-associated dry eye disease following short-term facemask wear among health workers at National hospital Abuja
Official scientific title Mask-associated dry eye disease following short-term facemask wear among health workers at National hospital Abuja
Brief summary describing the background and objectives of the trial BACKGROUND: Mask Associated Dry eye disease (MADE) is a new disease entity in the spectrum of dry eye disorders that has been linked to facemask use predominantly because of the upward flow of expired air trapped by the mask towards the eyes, which wrap around the ocular surface and induce dry eye and several ocular surface modifications. MADE was defined as a condition in which dry eye symptoms were present sometimes or worsened after wearing a face mask. Proper fitting of masks and taping the rim of the mask to the nasal bridge has been proposed to reduce these effects. RATIONALE: Health workers still wear facemasks routinely, and dry eye disease reduces quality of life and can lead to significant visual impairment. Few studies have been done on MADE in our environment, and the result of the study can set the stage for future research on modification of mask wear/design to reduce the negative effects on the eye, or introduce healthier alternatives to the current facemask designs. AIM: To determine the short-term effect of facemask wear, with or without taping the nasal bridge, on dry eye symptomatology and ocular surface stability of health workers at the National Hospital Abuja, with the purpose of making recommendations for a safer use of face masks by health workers. OBJECTIVES • To describe the changes in dry eye symptom score of health workers in National Hospital Abuja before and after 6 hours of face mask wear with or without taping the face mask over the nasal bridge. • To determine the effect of 6 hours of facemask wear with or without taping over the nasal bridge on ocular surface parameters (Tear Break-Up Time, Oxford corneal staining score, and Schirmer’s test 1) of health workers in National Hospital Abuja • To compare the difference in symptoms and signs when face mask is worn with taping and without taping over the nasal bridge. • To make recommendations for the proper safe use of face masks based on findings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/02/2024
Actual trial start date 26/02/2024
Anticipated date of last follow up 15/07/2024
Actual Last follow-up date 31/07/2024
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 77
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Surgical Facemask wear with taping at the nasal bridge 6 hours of facemask wear A 3.5inches X 0.5 inches adhesive facemask tape was applied to the inner part of the upper rim of the facemask and firmly pressed over the nasal bridge to ensure a firm fit. 77
Control Group Facemask wear without taping at the nasal bridge 6 hours A surgical facemask mask was worn for 6 hours without taping at the nasal bridge 77 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Consenting health workers of both sexes between 20 to 60 years of age in National Hospital Abuja with no prior ocular surface disease. 2.Screened health workers who did not have dry eye disease (symptoms + one positive tear homeostatic sign/test) following the pre-intervention assessment, and have been fully resident in Abuja in the week preceding the screening. 1.Health workers with a recent diagnosis of dry eye or other ocular surface diseases in the past 6 months (pterygium, conjunctivitis, keratitis, blepharitis, facial nerve palsy, etc.) 2. Presence of co-existing eye lid anomalies like ectropion, entropion, trichiasis, etc. 3. Health workers who were screened and found to have dry eye disease from the pre-intervention assessment. 4. Prior use of artificial tears, eye drops (anti-glaucoma medications, eye drops containing benzalkonium chloride preservative), or systemic medications (antidepressants, antipsychotics, and anxiolytics) which can affect the ocular surface within the last 3 months. 5. Previous eye surgeries including refractive and laser procedures. 6. Contact lens wear. 7. Participants with high refractive errors (more than 6 dioptres of myopia or hyperopia ) 8. Systemic co-morbidities like diabetes mellitus, hypertension, etc. 9. Pregnancy 10. Use of hormone replacement therapy. 11. Prior radiation therapy for facial tumors. 12. Respiratory diseases that may make participants non-compliant to wearing face masks for the duration of the study. 13. Health workers who routinely wear face masks for prolonged periods (continuously for more than 8 hours daily, 5 times a week in the last 2 months) such as those working for prolonged hours in isolation wards. 14. Health workers who declined consent. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 54 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2023 Health Research and Ethics Committee National Hospital Abuja.
Ethics Committee Address
Street address City Postal code Country
Plot 132 Cadastral Zone, Central Business District , Abuja, FCT, Nigeria Abuja 900103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dry eye symptom score Pre-facemask wear, Post 6 hours of facemask wear without taping, Post 6 hours of facemask wear with taping at the nasal bridge
Primary Outcome Schirmers test score Pre-facemask wear, Post 6 hours of facemask wear without taping, Post 6 hours of facemask wear with taping at the nasal bridge
Primary Outcome Tear break-up time Pre-facemask wear, Post 6 hours of facemask wear without taping, Post 6 hours of facemask wear with taping at the nasal bridge
Primary Outcome Oxford corneal staining score Pre-facemask wear, Post 6 hours of facemask wear without taping, Post 6 hours of facemask wear with taping at the nasal bridge
Secondary Outcome Development of Mask-Associated dry eye disease Post 6 hours of facemask wear without taping, Post 6 hours of facemask wear with taping at the nasal bridge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hospital Abuja Plot 132, Cadastral Zone, Central Business District Abuja 900103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Amaefuna Kosisochukwu Plot 132 Cadastral zone , Central Business district Abuja 900103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amaefuna Kosisochukwu Plot 132 Cadastral Zone, central Business District Abuja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kosisochukwu Amaefuna kosyamaefuna@gmail.com +2348157922298 Department of Ophthalmology, National Hospital Abuja, Plot 132 Cadastral Zone, central Business District
City Postal code Country Position/Affiliation
Abuja 900103 Nigeria Ophthalmologist
Role Name Email Phone Street address
Public Enquiries Kosisochukwu Amaefuna kosyamaefuna@gmail.com +2348157922298 Department of Ophthalmology, National Hospital Abuja, Plot 132 Cadastral Zone, central Business District
City Postal code Country Position/Affiliation
Abuja 900103 Nigeria Ophthalmologist
Role Name Email Phone Street address
Scientific Enquiries Kosisochukwu Amaefuna kosyamaefuna@gmail.com +2348157922298 Department of Ophthalmology, National Hospital Abuja, Plot 132 Cadastral Zone, central Business District
City Postal code Country Position/Affiliation
Abuja Nigeria Ophthalmologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The shared IPD will include deidentified data for each enrolled participant including: baseline demographics, outcome variables (Dry eye symptom score, tear break-up time, Schirmer's test scores and Oxford corneal staining scores), and dry eye disease incidence following facemask wear. Data will be shared in Microsoft Excel formats. Only study ID numbers will be included and all identifiers will be stripped. Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be immediately after publication up to 10 years post-publication CONTROL: The access criteria will be controlled, and access will be granted to ophthalmologists, researchers and academic institutions conducting similar research on ocular surface changes following facemask wear. TYPE OF ANALYSIS: Individual participant meta-analysis will be the type of data analysis permitted. DATA REQUEST PROCESS: This will be by sending an email to the principal investigator at kosyamaefuna@gmail.com. Access will be granted after submission of a short research proposal, institutional ethics approval and signing a data use agreement. The data will be shared after deidentification through a secure google drive link. REVIEW CRITERIA: The submissions will be reviewed by the principal investigator and will be based on the quality of the research methodology, validity of submitted ethical approval and its basis on ocular surface changes or facemask wear.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/07/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/07/2025 Result - 30/07/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 31/07/2025 Modification of title to Capital and Small letters. MASK-ASSOCIATED DRY EYE DISEASE FOLLOWING SHORT-TERM FACEMASK WEAR AMONG HEALTH WORKERS AT NATIONAL HOSPITAL ABUJA Mask-associated dry eye disease following short-term facemask wear among health workers at National hospital Abuja
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 31/07/2025 Modification of title to Capital and Small letters. MASK-ASSOCIATED DRY EYE DISEASE FOLLOWING SHORT-TERM FACEMASK WEAR AMONG HEALTH WORKERS AT NATIONAL HOSPITAL ABUJA Mask-associated dry eye disease following short-term facemask wear among health workers at National hospital Abuja
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 31/07/2025 PACTR Admin Self funded by Amaefuna Kosisochukwu, Plot 132 Cadastral zone , Central Business district , Abuja, 900103, Nigeria, Self Funded, Amaefuna Kosisochukwu, Plot 132 Cadastral zone , Central Business district , Abuja, 900103, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 31/07/2025 To effect the corrections after trial review. The study protocol chat, summary of results and informed consent are included in this section. The shared IPD will include deidentified data for each enrolled participant: baseline demographics, outcome variables (Dry eye symptom score, tear break-up time, Schirmer's test scores and Oxford corneal staining scores), and dry eye disease incidence following facemask wear. Data will be shared in Microsoft Excel formats. Only study ID numbers will be included and all identifiers will be stripped.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 31/07/2025 To effect the corrections after trial review. The shared IPD will include deidentified data for each enrolled participant: baseline demographics, outcome variables (Dry eye symptom score, tear break-up time, Schirmer's test scores and Oxford corneal staining scores), and dry eye disease incidence following facemask wear. Data will be shared in Microsoft Excel formats. Only study ID numbers will be included and all identifiers will be stripped. The shared IPD will include deidentified data for each enrolled participant including: baseline demographics, outcome variables (Dry eye symptom score, tear break-up time, Schirmer's test scores and Oxford corneal staining scores), and dry eye disease incidence following facemask wear. Data will be shared in Microsoft Excel formats. Only study ID numbers will be included and all identifiers will be stripped.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 31/07/2025 To effect the corrections after trial review. 2 years This will be immediately after publication up to 10 years post-publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 31/07/2025 To effect the corrections after trial review. The access criteria will be open CONTROL: The access criteria will be controlled, and access will be granted to ophthalmologists, researchers and academic institutions conducting similar research on ocular surface changes following facemask wear. TYPE OF ANALYSIS: Individual participant meta-analysis will be the type of data analysis permitted. DATA REQUEST PROCESS: This will be by sending an email to the principal investigator at kosyamaefuna@gmail.com. Access will be granted after submission of a short research proposal, institutional ethics approval and signing a data use agreement. The data will be shared after deidentification through a secure google drive link. REVIEW CRITERIA: The submissions will be reviewed by the principal investigator and will be based on the quality of the research methodology, validity of submitted ethical approval and its basis on ocular surface changes or facemask wear.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 31/07/2025 To effect the corrections after trial review. Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form