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Trial registered on ANZCTR


Registration number
ACTRN12621001289808
Ethics application status
Approved
Date submitted
27/08/2020
Date registered
23/09/2021
Date last updated
23/09/2021
Date data sharing statement initially provided
23/09/2021
Date results information initially provided
23/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation
Scientific title
Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation in healthy adults
Secondary ID [1] 302088 0
Nil known.
Universal Trial Number (UTN)
U1111-1257-2087
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal sensation 318700 0
Condition category
Condition code
Eye 316714 316714 0 0
Normal eye development and function
Anaesthesiology 316715 316715 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 2. Subjects will receive 1 drop of placebo (balanced salt solution) and two of 0.5% tetracaine hydrochloride ophthalmic solution at 3 minutes intervals topically in the right eye.
Group 3. This group will receive 3 drops of 0.5% tetracaine hydrochloride ophthalmic at 3 minutes intervals topically in the right eye.
Strategy to monitor adherence: drops were applied by a physician different from the physician measuring corneal sensation. Patients did not have to apply any drop by themselves nor were given any medication to withhold during the intervention period.
Placebo: balanced salt solution (BSS®, Alcon Laboratories, Inc.) composition per mL includes sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid, and water for injection.
Intervention code [1] 318387 0
Treatment: Drugs
Comparator / control treatment
Group 1. Subjects will receive 2 drops of placebo (balanced salt solution) and 1 drop of 0.5% tetracaine hydrochloride ophthlamic solution, applied topically at 3 minutes intervals in the right eye.
Control group
Dose comparison

Outcomes
Primary outcome [1] 324858 0
Corneal sensation measured with a handheld Cochet-Bonnet aesthesiometer.
Timepoint [1] 324858 0
Corneal sensation was measured at baseline, and every 3 minutes after intervention until minute 63. Primary timepoint is minute 63 after drug administration.
Secondary outcome [1] 385974 0
Presence of any adverse event described in association with the use of tetracaine: chemosis, lacrimation, transient conjunctival hyperemia, burning and photophobia. Assessed at slitlamp after recovery of baseline sensation.
Timepoint [1] 385974 0
After recovery of baseline sensation, or after 63 minutes from drug administration.
Secondary outcome [2] 385975 0
Presence of an epithelial defect greater than 1mm. assessed at slit-lamp using the cobalt blue filter, after the instilation of fluoresceine sodium drop (from an ophthalmic strip and a drop of balanced salt solution). Defect size was measured by silt beam.
Timepoint [2] 385975 0
After recovery of baseline sensation, or after 63 minutes from drug administration.

Eligibility
Key inclusion criteria
Healthy subjects.
18 years old or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any known systemic disease.
• Any known ophthalmic disease.
• Contact lens wear.
• Previous ophthalmic surgery.
• The presence of symptoms or signs of any ophthalmic disease.

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)
Allocation involved contacting the holder of the allocation schedule who was at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
ID numbers from 1 to 75 will be randomized with the software QuickCalcs; Random number Generator (GraphPad Software, San Diego, California USA, www.graphpad.com) to one of three groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The duration of maximal anesthetic effect, and the duration of corneal anesthesia, will be described as means with standard deviation in case of a normal distribution of data. Conversely, they will be described as medians with 95% confidence interval; an ANOVA/ Kruskal-Wallis test will be employed to compare more than three measures of the esthesiometry depending on data distribution. Additionally, Tukey post-hoc test will be employed.
The degree of the maximal anesthetic effect will be described as mean with standard deviation or median with 95% confidence interval and compared with the same statistical methods than the main outcomes.
Categorical analysis based on proportions will be evaluated by Chi-square test or exact Fisher’s test.
Shapiro-Wilk normality test will be used to determine distribution of all variables of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/12/2019
Date of last participant enrolment
Anticipated
Actual
27/12/2019
Date of last data collection
Anticipated
Actual
28/12/2019
Sample size
Target
75
Accrual to date
Final
81
Recruitment outside Australia
Country [1] 22867 0
Mexico
State/province [1] 22867 0
Yucatán

Funding & Sponsors
Funding source category [1] 306509 0
Hospital
Name [1] 306509 0
Hospital General Regional No. 12 "Lic. Benito Juarez"
Country [1] 306509 0
Mexico
Primary sponsor type
University
Name
Universidad Autónoma de Yucatán
Address
Itzaes Avenue wihtout number, corner with Hidalgo Street, at Regional General Hospital Number 12 "Lic. Benito Juárez", Colonia García Ginerés, City: Mérida. State: Yucatán. P.C. 97070.
Country
Mexico
Secondary sponsor category [1] 309427 0
None
Name [1] 309427 0
Address [1] 309427 0
Country [1] 309427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306711 0
Comité Local de Ética e Investigación en Salud (CLIEIS) (Local ethics committee on health and research) 3202
Ethics committee address [1] 306711 0
Hidalgo St. corner with Itzaes Av. without number, at Regional General Hospital Number 12 "Lic. Benito Juárez", Colonia García Ginerés. City: Merida. State: Yucatan. Country: Mexico. P.C. 97070.
Ethics committee country [1] 306711 0
Mexico
Date submitted for ethics approval [1] 306711 0
24/08/2019
Approval date [1] 306711 0
03/09/2019
Ethics approval number [1] 306711 0
R-2019-3202-005

Summary
Brief summary
Primary purpose. To measure and to compare the anesthetic effect of 1, 2 or 3 drops of 0.5% tetracaine hydrochloryde, at 3 minutes intervals on corneal sensation.
Hypothesis. The anesthetic effect will be greater at a greater dosage of tetracaine.
Trial website
Trial related presentations / publications
Public notes
The final work was presented in support for candidature for academic degree as ophthalmologist surgeon by the author Navarro-Saucedo R. This protocol was originally written in spanish. It has been translated to english for publication. The original version in spanish was made following the insitutional format. It was adapted from its original version in spanish to the 2013 SPIRIT guidelines for publication.

Contacts
Principal investigator
Name 104758 0
Dr Ricardo Navarro-Saucedo
Address 104758 0
Asociación para Evitar la Ceguera en México, I.A.P., Vicente García Torres 46, Colonia Barrio San Lucas, Coyoacán, Mexico City, Mexico. P.C. 04030
Country 104758 0
Mexico
Phone 104758 0
+52 4731623970
Fax 104758 0
Email 104758 0
A17017675@alumnos.uady.mx
Contact person for public queries
Name 104759 0
Roberto Gonzalez-Salinas
Address 104759 0
Asociación para Evitar la Ceguera en México, I.A.P., Vicente García Torres 46, Colonia Barrio San Lucas, Coyoacán, Mexico City, Mexico. P.C. 04030
Country 104759 0
Mexico
Phone 104759 0
+52 5510841400
Fax 104759 0
Email 104759 0
dr.gonzalezsalinas@gmail.com
Contact person for scientific queries
Name 104760 0
Roberto Gonzalez-Salinas
Address 104760 0
Asociación para Evitar la Ceguera en México, I.A.P., Vicente García Torres 46, Colonia Barrio San Lucas, Coyoacán, Mexico City, Mexico. P.C. 04030
Country 104760 0
Mexico
Phone 104760 0
+52 5510841400
Fax 104760 0
Email 104760 0
dr.gonzalezsalinas@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data base containing demographics, baseline corneal sensation, subject ID, baseline corneal sensation, corneal sensation measurements after intervention every three minutes until 63 minutes or baseline corneal sensation recovery.
When will data be available (start and end dates)?
From publication date to indefinite date.
Available to whom?
only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims in the approved proposal, and for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator and/or corresponding author:
PI: Ricardo Navarro-Saucedo
e-mail address: A17017675@alumnos.uady.mx


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8871Study protocol    380425-(Uploaded-20-08-2020-13-53-28)-Study-related document.docx
8872Informed consent form    380425-(Uploaded-20-08-2020-13-58-15)-Study-related document.docx
8874Ethical approval    380425-(Uploaded-20-08-2020-14-00-11)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.