Completed

A One-month, Randomized, Single Centre, Double-masked, Comparative Study to Evaluate the Short-term Ocular Effects of Experimental BHVI2 and 0.02% Atropine Eye Drops Either Alone or in Combination

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What is being tested

Experimental BHVI2

+ Atropine sulfate 0.02% eye drops

+ Combination eye drops

DrugCombination Product
Who is being recruted

Eye Diseases

+ Myopia

+ Refractive Errors

From 6 to 13 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 1
Interventional
Study Start: October 2018
See protocol details

Summary

Principal SponsorHai Yen Eye Care
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2018

Actual date on which the first participant was enrolled.

Atropine was proven to be effective in controlling myopia. 7-methylxanthine was considered to play a role in slowing myopia. The experimental BHVI2 eye drops were proven to be safe for in-eye use in the trial that was conducted in Sydney, Australia. The investigators wish to evaluate the effects of experimental BHVI2 and 0.02% atropine eye drops either alone or in combination mainly on the pupillary and accommodative responses in children aged between 6 to 13 years old over a one-month period.

Official TitleA One-month, Randomized, Single Centre, Double-masked, Comparative Study to Evaluate the Short-term Ocular Effects of Experimental BHVI2 and 0.02% Atropine Eye Drops Either Alone or in Combination
NCT03690414
Principal SponsorHai Yen Eye Care
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMyopiaRefractive Errors

Criteria

Inclusion Criteria: * be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and give informed consent as demonstrated by signing a record of informed consent; * at baseline, be within the age range of 6 to 13 years old inclusive; * be diagnosed as myopic having spherical equivalent between -0.50 diopter and-6.00 diopter. * willing to comply with the applying eye drops once nightly at bedtime and follow the clinical trial visit schedule as directed by the Investigator. * be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; * have ocular findings deemed to be normal * vision correctable to at least 20/25 or better in each eye with spectacles Exclusion Criteria: Subjects enrolled in the trial must NOT have: * Any pre-existing ocular irritation, allergic conjunctivitis, injury or condition, including infection or disease. * Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. * Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. * Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. * NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. * History of eye trauma * History of use of myopia control interventions such as Orthokeratology or eye surgery. * Contraindications to atropine and caffeine such as pulmonary disease, heart conditions and ADHD * Known allergy or intolerance to ingredients to atropine eye-drops, xanthines and other derivatives of anti-muscarinic receptor agents. * Currently enrolled in another clinical trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
20 participants will receive one drop per eye every night for four weeks.

Group II

Active Comparator
20 participants will receive one drop per eye every night for four weeks.

Group III

Active Comparator
20 participants will receive one drop per eye every night for four weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Ophthalmology - An Sinh Hospital

Ho Chi Minh City, VietnamOpen Department of Ophthalmology - An Sinh Hospital in Google Maps
CompletedOne Study Center