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Trial registered on ANZCTR

Registration number

ACTRN12626001159347

Ethics application status

Approved

Date submitted

17/08/2026

Date registered

17/09/2026

Date last updated

17/09/2026

Date data sharing statement initially provided

17/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Tolerability of administration of cyclopentolate 1% eye drops in healthy adults: Study 1

Scientific title

Effect of differing modes of cyclopentolate 1% administration on tolerability and efficacy in healthy adults: Study 1

Additional trial identifiers [1]

CT-2026-CTN-02586-1

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Cycloplegia

Condition category

Condition code

Eye

Normal eye development and function

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

What is the drug/intervention: Cyclopentolate Hydrochloride 1% eye drops - micro drop and spray administration of TGA approved products
Dose: 1-2 drops (or spray doses) per eye
Duration of treatment: Study 1 (adults) 6x visits (total; 4x interventional, 2x comparator)
Mode of delivery: Topical (eye)
Adherence: Nil required, administered during study visit only
Who delivers it and their relevant expertise: Lead Researcher delivers the eye drop in micro-drop or spray form, lead researcher is a therapeutically qualified, AHPRA registered optometrist.
How is it delivered: Face to face, topical administration within study visits
How often and for how long: Study 1 total of 6x 1.5-2 hour study visits (4x interventional, 2x comparator) spaced at least 2 days apart,
Where is it delivered: Clinic/laboratory setting

Description of study conditions, each administered on a separate visit in randomised order:
1. Standard drop delivery (~30µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch & Lomb) (comparator)
2. Standard drop delivery (~40µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (comparator)
3. Micro-drop delivery (~10µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch and Lomb) (interventional)
4. Micro-drop delivery (~10µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (interventional)
5. Spray delivery (120-160µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch and Lomb) (interventional)
6. Spray delivery (120-160µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (interventional)

Description of administration protocols:
Standard drop delivery:
Standard eye drop delivery to the inferior fornix of open eyes, head slightly reclined and participant looking toward the ceiling

Micro-drop delivery:
Nanodropper device; No change to original drug prescribed dosage regimen or protocol. The device simply reduces the volume of the drop administered. The Nanodropper is attached to the existing eye dropper bottle and eye drops are instilled as per standard cyclopentolate administration to the inferior fornix of open eyes, head slightly reclined and participant looking toward the ceiling.

Spray delivery:
Fine Mist Fingertip Sprayer (S703WH) and 6ml Amber Glass Bottle; The participant is to close their eyes (gently where possible) and maintain an upright position. Holding the spray bottle upright and directed slightly downwards towards the superior lash line, administer one to two metered sprays to each of the closed eyes in quick succession from approximately 3-5cm away to induce pupil dilation. The participant is then asked to open eyes and blink for 5-10 seconds to allow the drug to enter the tear film. The participant is advised to not touch/rub their eye directly, however any excess drug on the surface of the skin can be blotted away with a tissue.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Drugs

Intervention code [3]

Treatment: Devices

Description of the comparator or control

Control drug: Cyclopentolate Hydrochloride 1% TGA approved products in standard eye drop form
Dose: 1-2 drops to each eye
Duration of treatment: Study 1 (adults) 6x visits (total; 4x interventional, 2x comparator)
Mode of delivery: Topical (eye)
Adherence: Nil required, administered during study visit only
Who delivers it and their relevant expertise: Lead Researcher delivers the eye drop in micro-drop or spray form, lead researcher is a therapeutically qualified, AHPRA registered optometrist.
How is it delivered: Face to face, topical administration within study visits
How often and for how long: Study 1 total of 6x 1.5-2 hour study visits (4x interventional, 2x comparator) spaced at least 2 days apart,
Where is it delivered: Clinic/laboratory setting

There are two comparators/control treatments.
1. Standard drop delivery (~30µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch & Lomb)
2. Standard drop delivery (~40µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon)

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome [1] Tolerability: sting.

Timepoint [1]

This will be administered within two minutes of instilling cyclopentolate 1%.

Primary outcome [2]

Primary outcome [2] Tolerability: ocular irritation - bulbar conjunctival redness

Timepoint [2]

Ocular irritation experienced in response to each experimental condition will be measured immediately post cyclopentolate administration (within 5 minutes).

Primary outcome [3]

Primary outcome [3] Tolerability: ocular irritation – limbal conjunctival redness

Timepoint [3]

Ocular irritation experienced in response to each experimental condition will be measured immediately post cyclopentolate administration (within 5 minutes).

Secondary outcome [1]

Primary outcome [4] Tolerability: ocular irritation – first non-invasive keratograph break-up time (NIKBUT- first)

Timepoint [1]

Ocular irritation experienced in response to each experimental condition will be measured immediately post cyclopentolate administration (within 5 minutes).

Secondary outcome [2]

Primary outcome [5] Tolerability: ocular irritation – average non-invasive keratograph break-up time (NIKBUT- average)

Timepoint [2]

Ocular irritation experienced in response to each experimental condition will be measured immediately post cyclopentolate administration (within 5 minutes).

Secondary outcome [3]

Primary outcome [6] Cycloplegic efficacy: Objective accommodative response

Timepoint [3]

Time points for data collection are baseline (pre-instillation) and then 5, 10, 15, 20, 30, 40, 45, 50, 55, 60 mins post experimental condition administration or until 3 consecutive measures within 0.25D are collected.

Secondary outcome [4]

Primary outcome [7] Cycloplegic efficacy: Maximum stabilised distance refraction

Timepoint [4]

Secondary outcome [5]

Primary outcome [8] Cycloplegic efficacy: Subjective accommodative amplitude

Timepoint [5]

Time points for data collection are baseline (pre-instillation) and then 5, 10, 15, 20, 30, 40, 45, 50, 55, 60 mins post experimental condition administration.

Secondary outcome [6]

Primary outcome [9] Mydriatic efficacy: Photopic pupil diameter

Timepoint [6]

Time points for data collection are baseline (pre-instillation) and then 5, 10, 15, 20, 30, 40, 45, 50, 55 and 60 mins post experimental condition administration or until 3 consecutive measures within 0.3 mm are collected (allowing 10% standard deviation for documented accuracy of device of 0.03 mm), whichever occurs last.

Secondary outcome [7]

Secondary outcome [1] Mydriatic efficacy: Pupillary light reflex

Timepoint [7]

Pupillary light reflex will be measured by researcher at baseline (pre-instillation) and then 5, 10, 15, 20, 30, 40, 45, 50, 55 and 60 mins post experimental condition administration or until no pupil response to light is noted, whichever occurs first.

Secondary outcome [8]

Secondary outcome [2] Biometry - observational change in axial length

Timepoint [8]

Baseline (pre-administration) and then 10, 30, 60 minutes post administration of experimental condition.

Secondary outcome [9]

Secondary outcome [3] Biometry - observational change anterior chamber depth

Timepoint [9]

Baseline (pre-administration) and then 10, 30, 60 minutes post administration of experimental condition.

Secondary outcome [10]

Secondary outcome [4] Biometry - observational change lens thickness

Timepoint [10]

Baseline (pre-administration) and then 10, 30, 60 minutes post administration of experimental condition.

Eligibility

Key inclusion criteria

Study 1: Healthy adults between 18-39 years of age with a range of refractive error (+10 to -10 dioptres (spherical equivalent)) and iris colour, and age normal amplitude of accommodation.

Minimum age

18 Years

Maximum age

39 Years

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

Any contraindications to receiving cyclopentolate hydrochloride including:
History of - cardiovascular disorders, Down’s syndrome or any organic brain syndromes (including congenital or neurodevelopmental abnormalities), diabetes, severe cognitive impairment or severe medical conditions making it difficult to understand and respond appropriately to questions, currently pregnant or breastfeeding, glaucoma or intraocular pressure greater than 21mmHg in each eye, narrow anterior chamber angles, ocular disease (excluding refractive error and/or strabismus), amblyopia (BCVA worse than 6/9.5 and/or worse than N5 vision at near in either eye), astigmatism greater than 1.5D, ocular trauma or surgery, pupil abnormalities, contact lens wear or dry eye syndrome, NIKBUT-average time of 7s or lower, known allergy or hypersensitivity to cyclopentolate and/or atropine, current prescribed eye drop use of any kind.
In the opinion of the lead researcher, be unwilling or unable to comply with the trial protocol.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed - Trial is not masked, and has been designed as repeated measures study where all participants will cycle through all conditions, therefore no concealed allocation required.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

For Study 1, using Microsoft Excel randomise function, order of experimental conditions 1-6 (4x intervention conditions and 2x comparator conditions) will be randomly assigned to each participant at the Screening (Visit 1) or at time of recruitment.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Using G*Power, for Study 1 (adult population) minimum sample size of six participants is required for a repeated-measures ANOVA within factors design, to achieve a power of 80% (as recommended by the FDA), and assuming a moderate effect size (0.5) and p value of 0.05 as defined by Cohen. To account for a 20% attrition rate, and to ensure power of the study beyond 80%, 15 participants will be recruited for Study 1.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

21/09/2026

Actual

Date of last participant enrolment

Anticipated

18/10/2027

Actual

Date of last data collection

Anticipated

30/10/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology

Address [1]

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Research Training Program (RTP) Stipend Scholarship

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

Queensland University of Technology

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland University of Technology University Human Research Ethics Committee

Ethics committee address [1]

https://www.qut.edu.au/research/why-qut/ethics-and-integrity

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/08/2025

Approval date [1]

19/06/2026

Ethics approval number [1]

9823

Summary

Brief summary

Cyclopentolate 1% is the recommended drug of choice to induce cycloplegia during paediatric eye examinations. Cycloplegia forms part of the standard of care in the diagnosis and management of refractive error, strabismus, and ocular disease in children. Given this procedure is required for best practice, it is concerning that instillation of cyclopentolate eyedrops can cause significant distress to children during eye examinations due to sting on instillation and discomfort during the administration process. Variables that contribute to sting and discomfort include the low pH of commercially available formulations of cyclopentolate, the size of the eye drop, and the mode of administration.
This project aims to assess the effects that these variables have on sting and distress by comparing the sting and discomfort of the two commercially available, TGA approved formulations, Cyclogyl (Alcon) and Cyclopentolate Minims (Bausch and Lomb) (with differing pH levels) administered via alternative delivery methods (micro-drop to reduced drop size and spray to alter administration mode) to study participants. The tolerability and efficacy of a final alternative delivery method (micro-drop or spray) and with which cyclopentolate product (Minims or Cyclogyl) will be determined in adults through Study 1, before being administered to children in Study 2 (to be registered at a later date once data analysis is completed and 'final alternative delivery method' determined from Study 1).  Even though cyclopentolate eye drops are the drug of choice for cycloplegia in children, recruiting adults for Study 1 will help to alleviate unnecessary burden of repeated visits and procedural anxiety on children.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Shelley Hopkins

Address

Queensland University of Technology - Kelvin Grove Campus, O Block, D Wing, Ring Road (Via Herston Road), Kelvin Grove 4059 QLD

Country

Australia

Phone

+61 7 3138 8617

Fax

[email protected]

Contact person for public queries

Name

Candice Pearson

Address

Queensland University of Technology - Kelvin Grove Campus, O Block, D Wing, Ring Road (Via Herston Road), Kelvin Grove 4059 QLD

Country

Australia

Phone

+61 7 3138 5697

Fax

[email protected]

Contact person for scientific queries

Name

Candice Pearson

Address

Queensland University of Technology - Kelvin Grove Campus, O Block, D Wing, Ring Road (Via Herston Road), Kelvin Grove 4059 QLD

Country

Australia

Phone

+61 7 3138 5697

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee

• Participant must have circled 'yes' in response to 'I give permission for data from this study to be used in future research projects' on PICF for us to facilitate sharing of individual participant data (see attached PICF for Study 1)

What individual participant data might be shared?

• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After completion of first data analysis
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Email lead researcher Candice Pearson ([email protected])

Are there extra considerations when requesting access to individual participant data?

Yes: Participant must have circled 'yes' in response to 'I give permission for data from this study to be used in future research projects' on PICF for us to facilitate sharing of individual participant data (see attached PICF for Study 1).

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					9823_Approval.pdf
Informed consent form				PICF Study 1 (adults)	PIC_Cyclopentolate_PICF_Adults_STUDY1_V3.1_20260615_CLEAN.docx

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.

Trial Review

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Documents added automatically