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Trial registered on ANZCTR
Registration number
ACTRN12619001394134
Ethics application status
Approved
Date submitted
10/08/2019
Date registered
11/10/2019
Date last updated
11/10/2019
Date data sharing statement initially provided
11/10/2019
Date results information initially provided
11/10/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Effects of Oxymetazoline Nasal Spray after Dacryocystorhinostomy Among Adult Patients
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Scientific title
A Randomized Controlled Trial on the Effects of Oxymetazoline Nasal Spray after Dacryocystorhinostomy
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Secondary ID [1]
298989
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
post-operative congestion
313986
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post-operative pain
313991
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post-operative bleeding
313992
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nasolacrimal obstruction
314109
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Condition category
Condition code
Eye
312381
312381
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0
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Diseases / disorders of the eye
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Surgery
312488
312488
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention group used 0.05% oxymetazoline nasal spray post-operatively, instilled twice a day (8AM and 8PM), on the operated side for the first 3 days. The administration of the medication was done by a separate single investigator while the patient was admitted in the hospital ward to ensure adherence.
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Intervention code [1]
315255
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Treatment: Drugs
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Comparator / control treatment
The placebo group used 0.65% NaCl nasal spray post-operatively, instilled twice a day (8AM and 8PM), on the operated side for the first 3 days. The administration of the medication was done by a separate single investigator while the patient was admitted in the hospital ward to ensure adherence.
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Control group
Placebo
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Outcomes
Primary outcome [1]
321020
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The primary outcome was the finding of patency demonstrated by clinical observation of egress of fluorescein-stained (yellow-stained) fluid from the fistula while doing lacrimal apparatus irrigation. The patency was defined as open-ness of the fistula.
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Assessment method [1]
321020
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Timepoint [1]
321020
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Pre-operative (baseline), days 2 and 16 post-operation, and 6 months post-operation (primary endpoint)
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Secondary outcome [1]
373704
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the incidence of post-operative congestion versus placebo using a questionnaire designed specifically for this study
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Assessment method [1]
373704
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Timepoint [1]
373704
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days 2 and 16 post-operation
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Secondary outcome [2]
374090
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the incidence of post-operative pain versus placebo using a questionnaire designed specifically for this study
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Assessment method [2]
374090
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Timepoint [2]
374090
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days 2 and 16 post-operation
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Secondary outcome [3]
374091
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the incidence of post-operative bleeding versus placebo using a questionnaire designed specifically for this study
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Assessment method [3]
374091
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Timepoint [3]
374091
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days 2 and 16 post-operation
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Secondary outcome [4]
374092
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findings of patency by nasal endoscopy; The patency was defined as open-ness of the fistula.
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Assessment method [4]
374092
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Timepoint [4]
374092
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days 2 and 16 post-operation
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Secondary outcome [5]
374093
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findings of presence of silicone tube placed during the surgery in the fistula by nasal endoscopy
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Assessment method [5]
374093
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Timepoint [5]
374093
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days 2 and 16 post-operation
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Secondary outcome [6]
374094
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findings of granuloma formation by nasal endoscopy
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Assessment method [6]
374094
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Timepoint [6]
374094
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days 2 and 16 post-operation
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Secondary outcome [7]
374095
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findings of bleeding by nasal endoscopy
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Assessment method [7]
374095
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Timepoint [7]
374095
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days 2 and 16 post-operation
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Eligibility
Key inclusion criteria
Adult patients (>18 y/o) of sound mind who can consent for the study, diagnosed with primary acquired NLDO with clearance for external DCR under general anesthesia, and assessed with pre-operative nasal endoscopic evaluation as suitable by Investigator 3.For cases with bilateral obstruction, only one side was included in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The patients with the following characteristics were excluded from the study: previous lacrimal or nasal surgery; active inflammation of the lacrimal apparatus or nasal passages; known case of uncontrolled hypertension, diabetes or hyperthyroidism; use of monoamine oxidase inhibitor or tricyclic antidepressants; known allergy to oxymetazoline; or breastfeeding patients.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment using numbered containers by Investigator 1; Investigator 1 is not involved in determining if a patient will be included.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pemuted block randomization
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics were used to analyze the data. Fisher exact statistics was used for comparison of groups in terms of categorical variables. For the age, unpaired t-test was used. For the number of comorbidities, Kruskal-Wallis Rank sum test was used due to non-normality of data.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/06/2017
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Date of last participant enrolment
Anticipated
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Actual
31/08/2017
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Date of last data collection
Anticipated
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Actual
28/02/2018
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
21757
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Philippines
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State/province [1]
21757
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Manila
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Funding & Sponsors
Funding source category [1]
303528
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Hospital
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Name [1]
303528
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University of the Philippines Manila - Philippine General Hospital
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Address [1]
303528
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547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Country [1]
303528
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Philippines
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Primary sponsor type
Hospital
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Name
University of the Philippines Manila - Philippine General Hospital
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Address
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Country
Philippines
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Secondary sponsor category [1]
303593
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None
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Name [1]
303593
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Address [1]
303593
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Country [1]
303593
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304055
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University of the Philippines Manila Research Ethics Board
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Ethics committee address [1]
304055
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547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Ethics committee country [1]
304055
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Philippines
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Date submitted for ethics approval [1]
304055
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08/03/2017
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Approval date [1]
304055
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24/04/2017
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Ethics approval number [1]
304055
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(OVS) 2017-183-01
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Summary
Brief summary
The study aimed to determine the effect of oxymetazoline nasal spray after dacryocystorhinostomy, specifically: to compare the success of fistula formation with oxymetazoline versus placebo, and to compare the incidence of post-operative congestion, pain and bleeding with oxymetazoline versus placebo. The intervention group used oxymetazoline, while the placebo group used sodium chloride. The researchers hypothesized that after DCR, oxymetazoline nasal spray does not significantly decrease nasal discomfort compared to placebo. The researchers also hypothesized that after DCR, oxymetazoline nasal spray does not significantly improve fistula formation compared to placebo.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
95666
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Dr George Michael N. Sosuan
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Address
95666
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Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Country
95666
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Philippines
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Phone
95666
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+6325548400
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Fax
95666
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Email
95666
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[email protected]
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Contact person for public queries
Name
95667
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Dr George Michael N. Sosuan
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Address
95667
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Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Country
95667
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Philippines
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Phone
95667
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+6325548400
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Fax
95667
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Email
95667
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[email protected]
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Contact person for scientific queries
Name
95668
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Dr George Michael N. Sosuan
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Address
95668
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Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
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Country
95668
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Philippines
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Phone
95668
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+6325548400
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Fax
95668
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Email
95668
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data may unnecessary reveal the patient's identity.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3953
Ethical approval
378152-(Uploaded-10-08-2019-00-46-17)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
A randomized controlled trial on the effects of oxymetazoline nasal spray after dacryocystorhinostomy among adult patients
2020
https://doi.org/10.1186/s13104-020-05076-4
N.B. These documents automatically identified may not have been verified by the study sponsor.
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