Trial Review

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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
Scientific title
A Randomized Controlled Trial on the Effects of Oxymetazoline Nasal Spray after Dacryocystorhinostomy
Secondary ID [1] 298989 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative congestion 313986 0
post-operative pain 313991 0
post-operative bleeding 313992 0
nasolacrimal obstruction 314109 0
Condition category
Condition code
Eye 312381 312381 0 0
Diseases / disorders of the eye
Surgery 312488 312488 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315255 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 321020 0
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.
Timepoint [1] 321020 0
Pre-operative (baseline), days 2 and 16 post-operation, and 6 months post-operation (primary endpoint)
Secondary outcome [1] 373704 0
the incidence of post-operative congestion versus placebo using a questionnaire designed specifically for this study
Timepoint [1] 373704 0
days 2 and 16 post-operation
Secondary outcome [2] 374090 0
the incidence of post-operative pain versus placebo using a questionnaire designed specifically for this study
Timepoint [2] 374090 0
days 2 and 16 post-operation
Secondary outcome [3] 374091 0
the incidence of post-operative bleeding versus placebo using a questionnaire designed specifically for this study
Timepoint [3] 374091 0
days 2 and 16 post-operation
Secondary outcome [4] 374092 0
findings of patency by nasal endoscopy; The patency was defined as open-ness of the fistula.
Timepoint [4] 374092 0
days 2 and 16 post-operation
Secondary outcome [5] 374093 0
findings of presence of silicone tube placed during the surgery in the fistula by nasal endoscopy
Timepoint [5] 374093 0
days 2 and 16 post-operation
Secondary outcome [6] 374094 0
findings of granuloma formation by nasal endoscopy
Timepoint [6] 374094 0
days 2 and 16 post-operation
Secondary outcome [7] 374095 0
findings of bleeding by nasal endoscopy
Timepoint [7] 374095 0
days 2 and 16 post-operation

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pemuted block randomization
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
31/08/2017
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21757 0
Philippines
State/province [1] 21757 0
Manila

Funding & Sponsors
Funding source category [1] 303528 0
Hospital
Name [1] 303528 0
University of the Philippines Manila - Philippine General Hospital
Country [1] 303528 0
Philippines
Primary sponsor type
Hospital
Name
University of the Philippines Manila - Philippine General Hospital
Address
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
Country
Philippines
Secondary sponsor category [1] 303593 0
None
Name [1] 303593 0
Address [1] 303593 0
Country [1] 303593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304055 0
University of the Philippines Manila Research Ethics Board
Ethics committee address [1] 304055 0
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
Ethics committee country [1] 304055 0
Philippines
Date submitted for ethics approval [1] 304055 0
08/03/2017
Approval date [1] 304055 0
24/04/2017
Ethics approval number [1] 304055 0
(OVS) 2017-183-01

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95666 0
Dr George Michael N. Sosuan
Address 95666 0
Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
Country 95666 0
Philippines
Phone 95666 0
+6325548400
Fax 95666 0
Email 95666 0
gmsosuan@yahoo.com
Contact person for public queries
Name 95667 0
Dr George Michael N. Sosuan
Address 95667 0
Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
Country 95667 0
Philippines
Phone 95667 0
+6325548400
Fax 95667 0
Email 95667 0
gmsosuan@yahoo.com
Contact person for scientific queries
Name 95668 0
Dr George Michael N. Sosuan
Address 95668 0
Department of Ophthalmology and Visual Sciences
547 Pedro Gil Street, Ermita, Manila, 1000 Metro Manila, Philippines
Country 95668 0
Philippines
Phone 95668 0
+6325548400
Fax 95668 0
Email 95668 0
gmsosuan@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data may unnecessary reveal the patient's identity.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3953Ethical 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
SourceTitleYear of PublicationDOI
Dimensions AIA randomized controlled trial on the effects of oxymetazoline nasal spray after dacryocystorhinostomy among adult patients2020https://doi.org/10.1186/s13104-020-05076-4
N.B. These documents automatically identified may not have been verified by the study sponsor.