MyopiaPhase 1NCT03690414

Evaluation of Short Term Use of Experimental Eye Drops BHVI2, 0.02% Atropine and BHVI2 Plus 0.02% Atropine Eye Drops

A Phase 1 study testing Experimental BHVI2, Atropine sulfate 0.02% eye drops and Combination eye drops in people with Myopia, run by Hai Yen Eye Care at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the one-month ocular effects of nightly application of experimental BHVI2 and 0.02% atropine eye drops either alone or in combination, in children aged between 6 to 13 years old with myopia and randomized to use of experimental BHVI2 eye drops, 0.02% atropine eye drops, experimental BHVI2 plus 0.02% atropine… Read more about this study

Who is it for?: Ages 6 to 13 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Experimental BHVI2, Atropine sulfate 0.02% eye drops and Combination eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteVietnam
Study dates: 1 Oct 2018to 30 Jun 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 13 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Department of Ophthalmology - An Sinh Hospital
Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: 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

Read the detailed description

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.

Conditions: Myopia
Being tested: Experimental BHVI2, Atropine sulfate 0.02% eye drops, Combination eye drops
Keywords: Myopia control, Atropine eye drops, Caffeine eye drops, Pupillary diameter, Accommodative responses
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental BHVI2Drug
Experimental BHVI2 eye drops
Atropine sulfate 0.02% eye dropsDrug
Atropine eye drops
Combination eye dropsCombination product
Combination eye drops with experimental BHVI2 plus 0.02% atropine

Study groups in NCT03690414
Study group	Role	What they receive
Experimental BHVI2 eye drops	Active comparator	20 participants will receive one drop per eye every night for four weeks. Receives: Drug: Experimental BHVI2
0.02% Atropine eye drops	Active comparator	20 participants will receive one drop per eye every night for four weeks. Receives: Drug: Atropine sulfate 0.02% eye drops
Experimental BHVI2 plus 0.02% atropine	Active comparator	20 participants will receive one drop per eye every night for four weeks. Receives: Combination Product: Combination eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in pupillary diameter
Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops
Measured: At baseline, at two-week and one-month visits
Change in accommodative amplitude
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops
Measured: At baseline, at two-week and one-month visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201830 Jun 2019

First posted1 Oct 2018
Study start1 Oct 2018
Primary completion2 Feb 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Children aged between 6 to 13 years old. Myopia with spherical equivalent of -0.50D or worse with cylinder of -2.00D or less
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03690414
Sponsor's protocol ID: VCRTC-2018-01
Status last verified: Feb 2019
First submitted: 27 Sep 2018
Last updated: 12 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bruce A. Re: Holden et al.: Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050 (Ophthalmology 2016;123:1036-1042). Ophthalmology. 2017 Mar;124(3):e24-e25. doi: 10.1016/j.ophtha.2016.06.066. No abstract available.
PubMed 28219507
Sankaridurg PR, Holden BA. Practical applications to modify and control the development of ametropia. Eye (Lond). 2014 Feb;28(2):134-41. doi: 10.1038/eye.2013.255. Epub 2013 Dec 6.
PubMed 24310242
Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.
PubMed 26826749
Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.
PubMed 10048351
Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.
PubMed 26218150
Chatzistefanou KI, Mills MD. The role of drug treatment in children with strabismus and amblyopia. Paediatr Drugs. 2000 Mar-Apr;2(2):91-100. doi: 10.2165/00148581-200002020-00002.
PubMed 10937461
Chen AM, Cotter SA. The Amblyopia Treatment Studies: Implications for Clinical Practice. Adv Ophthalmol Optom. 2016 Aug;1(1):287-305. doi: 10.1016/j.yaoo.2016.03.007. No abstract available.
PubMed 28435934
Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
PubMed 26271839
Tran HDM, Tran YH, Tran TD, Jong M, Coroneo M, Sankaridurg P. A Review of Myopia Control with Atropine. J Ocul Pharmacol Ther. 2018 Jun;34(5):374-379. doi: 10.1089/jop.2017.0144. Epub 2018 May 1.
PubMed 29715053
Shih KC, Chan TC, Ng AL, Lai JS, Li WW, Cheng AC, Fan DS. Use of Atropine for Prevention of Childhood Myopia Progression in Clinical Practice. Eye Contact Lens. 2016 Jan;42(1):16-23. doi: 10.1097/ICL.0000000000000189.
PubMed 26340385
Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
PubMed 21963266
Chia A, Chua WH, Wen L, Fong A, Goon YY, Tan D. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.
PubMed 24315293
Chua WH, Balakrishnan V, Chan YH, Tong L, Ling Y, Quah BL, Tan D. Atropine for the treatment of childhood myopia. Ophthalmology. 2006 Dec;113(12):2285-91. doi: 10.1016/j.ophtha.2006.05.062. Epub 2006 Sep 25.
PubMed 16996612
Shih YF, Hsiao CK, Chen CJ, Chang CW, Hung PT, Lin LL. An intervention trial on efficacy of atropine and multi-focal glasses in controlling myopic progression. Acta Ophthalmol Scand. 2001 Jun;79(3):233-6. doi: 10.1034/j.1600-0420.2001.790304.x.
PubMed 11401629
North RV, Kelly ME. A review of the uses and adverse effects of topical administration of atropine. Ophthalmic Physiol Opt. 1987;7(2):109-14. doi: 10.1111/j.1475-1313.1987.tb01004.x.
PubMed 2958765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03690414
Acronym / sponsor ID: VCRTC-2018-01
Conditions: Myopia
Keywords: Myopia control, Atropine eye drops, Caffeine eye drops, Pupillary diameter, Accommodative responses
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Hai Yen Eye CareIndustry (pharma, biotech, devices)
Collaborators: Brien Holden Vision
Study start: 1 Oct 2018 (actual)
Primary completion: 2 Feb 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 1 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Children aged between 6 to 13 years old. Myopia with spherical equivalent of -0.50D or worse with cylinder of -2.00D or less

Arm	Type	Receives
Experimental BHVI2 eye drops	Active comparator	Drug: Experimental BHVI220 participants will receive one drop per eye every night for four weeks.
0.02% Atropine eye drops	Active comparator	Drug: Atropine sulfate 0.02% eye drops20 participants will receive one drop per eye every night for four weeks.
Experimental BHVI2 plus 0.02% atropine	Active comparator	Combination Product: Combination eye drops20 participants will receive one drop per eye every night for four weeks.

Who may qualify

Ages: 6 to 13 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental BHVI2Experimental BHVI2 eye drops	Drug	Experimental BHVI2 eye drops
Atropine sulfate 0.02% eye dropsAtropine eye drops	Drug	0.02% Atropine eye drops
Combination eye dropsCombination eye drops with experimental BHVI2 plus 0.02% atropine	Combination product	Experimental BHVI2 plus 0.02% atropine

Primary outcome

Change in pupillary diameter
Time frame: At baseline, at two-week and one-month visits
Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops
Change in accommodative amplitude
Time frame: At baseline, at two-week and one-month visits
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Background: PubMed 28219507Bruce A. Re: Holden et al.: Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050 (Ophthalmology 2016;123:1036-1042). Ophthalmology. 2017 Mar;124(3):e24-e25. doi: 10.1016/j.ophtha.2016.06.066. No abstract available.
Background: PubMed 24310242Sankaridurg PR, Holden BA. Practical applications to modify and control the development of ametropia. Eye (Lond). 2014 Feb;28(2):134-41. doi: 10.1038/eye.2013.255. Epub 2013 Dec 6.
Background: PubMed 26826749Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.
Background: PubMed 10048351Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.
Background: PubMed 26218150Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.
Background: PubMed 10937461Chatzistefanou KI, Mills MD. The role of drug treatment in children with strabismus and amblyopia. Paediatr Drugs. 2000 Mar-Apr;2(2):91-100. doi: 10.2165/00148581-200002020-00002.
Background: PubMed 28435934Chen AM, Cotter SA. The Amblyopia Treatment Studies: Implications for Clinical Practice. Adv Ophthalmol Optom. 2016 Aug;1(1):287-305. doi: 10.1016/j.yaoo.2016.03.007. No abstract available.
Background: PubMed 26271839Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
Background: PubMed 29715053Tran HDM, Tran YH, Tran TD, Jong M, Coroneo M, Sankaridurg P. A Review of Myopia Control with Atropine. J Ocul Pharmacol Ther. 2018 Jun;34(5):374-379. doi: 10.1089/jop.2017.0144. Epub 2018 May 1.
Background: PubMed 26340385Shih KC, Chan TC, Ng AL, Lai JS, Li WW, Cheng AC, Fan DS. Use of Atropine for Prevention of Childhood Myopia Progression in Clinical Practice. Eye Contact Lens. 2016 Jan;42(1):16-23. doi: 10.1097/ICL.0000000000000189.
Background: PubMed 21963266Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
Background: PubMed 24315293Chia A, Chua WH, Wen L, Fong A, Goon YY, Tan D. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huy D.M Tran, MD, MSc principal investigator

Hai Eye Eye Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Experimental BHVI2, Atropine sulfate 0.02% eye drops and Combination eye drops in people with Myopia, run by Hai Yen Eye Care at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pupillary diameter (time frame: At baseline, at two-week and one-month visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690414, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.