Myopia Control With Novel Eye Drops

NCT04301323 | Completed Phase 1 DMC

• 2 other identifiers: CS/AS/18/12VCRTC-2018-02
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Myopia currently affects 30% of the world and by 2050, almost 50% of the world will be myopic based on conservative estimates.1 In 2050, this will equate to almost 5 billion people with myopia, and those with high myopia will total almost 1 billion.1 Due to the growing public health concerns surrounding myopia, including treatments for visual complications associated with high myopia, the resultant lost productivity and increased cost to society, a solution to ameliorate this issue is imperative. Current treatment strategies cannot prevent myopia, and their ability to slow myopia progression is variable, ranging from 10% to 59%.2 Based on the meta-analysis between the different interventions for myopia control, atropine eye-drops were proved the most effective strategy.3 Atropine has been used in myopia control treatment over the last 30 years in many countries with no serious adverse events reported.4-6 Moreover, atropine, a non-selective antimuscarinic agent, has been regularly applied in multiple other ocular conditions with respect to the official FDA approvals.7 8 Regarding the myopia management, recent studies show the significant effect of low dose atropine in controlling the progression of spherical equivalent with the least side-effects such as photophobia and blurry near vision.9 However, the lack of substantial data in reducing the axial growth rate of low dose atropine proposes a need of either using higher dose of atropine or in combination with other pharmaceutical agent having such the effect. We therefore aim to determine in a two-year clinical trial, the efficacy of the eye drops used in our clinical trial for its role in slowing progression of myopia.

Conditions

Myopia

Keywords

Atropine; Combination eye drops; Myopia control

Outcome Measures

Primary Outcomes (1)

• Spherical equivalent

  Annual change in spherical equivalent from baseline

  at baseline visit, at one-year and two-year visits

Secondary Outcomes (1)

• Axial length

  at baseline visit, at one-year and two-year visits

Study Arms (4)

BHVI1

EXPERIMENTAL

BHVI1 eye drops

Drug: BHVI1 eye drops

BHVI2

EXPERIMENTAL

BHVI2 eye drops

Drug: BHVI2 eye drops

BHVI3

EXPERIMENTAL

Combination of BHVI1 and BHVI2 eye drops

Drug: BHVI3 eye drops

Non-randomized control group

NO INTERVENTION

a separate control group including 105 children enrolled and followed with only single-vision spectacles.

Interventions

BHVI1 eye drops DRUG

Including 35 children enrolled to receive BHVI1 eye-drops once nightly

Also known as: Novel BHVI1 eye drops

BHVI1

BHVI2 eye drops DRUG

Including 35 children enrolled to receive BHVI2 eye-drops once nightly

Also known as: Novel BHVI2 eye drops

BHVI2

BHVI3 eye drops DRUG

Including 35 children enrolled to receive BHVI3, combination of BHVI1 and BHVI2, eye-drops once nightly

Also known as: Novel BHVI3 eye drops

BHVI3

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 the products used in the trial such as pulmonary disease, heart conditions and ADHD
• Known allergy or intolerance to ingredients to eye-drops used in the trial and other related derivatives.
• Currently enrolled in another clinical trial.

Sponsors & Collaborators

• Hai Yen Eye Care: lead
• Brien Holden Vision Institute: collaborator

Study Sites (1)

Department of Ophthalmology - An Sinh Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (13)

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 BACKGROUND

• 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.

  PMID: 24310242 BACKGROUND

• 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.

  PMID: 26826749 BACKGROUND

• Brodstein RS, Brodstein DE, Olson RJ, Hunt SC, Williams RR. The treatment of myopia with atropine and bifocals. A long-term prospective study. Ophthalmology. 1984 Nov;91(11):1373-9. doi: 10.1016/s0161-6420(84)34138-0.

  PMID: 6514306 BACKGROUND

• 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.

  PMID: 10048351 BACKGROUND

• 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.

  PMID: 26218150 BACKGROUND

• 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.

  PMID: 10937461 BACKGROUND

• 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.

  PMID: 28435934 BACKGROUND

• 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.

  PMID: 26271839 BACKGROUND

• Fan DS, Lam DS, Chan CK, Fan AH, Cheung EY, Rao SK. Topical atropine in retarding myopic progression and axial length growth in children with moderate to severe myopia: a pilot study. Jpn J Ophthalmol. 2007 Jan-Feb;51(1):27-33. doi: 10.1007/s10384-006-0380-7. Epub 2007 Feb 9.

  PMID: 17295137 BACKGROUND

• Kennedy RH, Dyer JA, Kennedy MA, Parulkar S, Kurland LT, Herman DC, McIntire D, Jacobs D, Luepker RV. Reducing the progression of myopia with atropine: a long term cohort study of Olmsted County students. Binocul Vis Strabismus Q. 2000;15(3 Suppl):281-304.

  PMID: 11486796 BACKGROUND

• Yen MY, Liu JH, Kao SC, Shiao CH. Comparison of the effect of atropine and cyclopentolate on myopia. Ann Ophthalmol. 1989 May;21(5):180-2, 187.

  PMID: 2742290 BACKGROUND

• Cooper J, Eisenberg N, Schulman E, Wang FM. Maximum atropine dose without clinical signs or symptoms. Optom Vis Sci. 2013 Dec;90(12):1467-72. doi: 10.1097/OPX.0000000000000037.

  PMID: 24076540 BACKGROUND

Related Links

• Brien Holden Vision Institute
• Hai Yen Eye Care
• An Sinh Hospital
• School of Optometry and Vision Science - University of New South Wales, Vietnam

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Padmaja Sankaridurg, Professor

  Brien Holden Vision Institute; School of Optometry and Vision Science - University of New South Wales

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the interventions group, the participants and the investigators will be masked to the nature of the drop dispensed. Upon receiving the product, the product will be coded and masked by a person other than the clinicians involved in the study. Only coded and masked product will be dispensed to the participant. Unmasking should only occur in the case of an adverse event if knowledge of the trial treatment would alter the plan of care for the participant. If at all possible (if time permits) the Sponsor / The Independent Pharmacist should be consulted prior to unmasking. Thorough documentation must occur, and exposure to treatment knowledge should be limited only to those who must know.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the intervention group, there will be a minimum of 105 participants enrolled with the participants randomised to 3 groups of 35 in each group to receive either BHVI1, BHVI2 , or BHVI3 per group. In the non-randomized, matched control group, there will be 105 other participants recruited with similar inclusion and exclusion criteria and similar procedures as outlined but without any eye drops.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: October 26, 2019
• Primary Completion: June 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 22, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)