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

NCT03690414 | Completed Phase 1 DMC

• 1 other identifier: VCRTC-2018-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 eye drops.

Conditions

Myopia

Keywords

Myopia control; Atropine eye drops; Caffeine eye drops; Pupillary diameter; Accommodative responses

Outcome Measures

Primary Outcomes (2)

• Change in pupillary diameter

  Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops

  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

  At baseline, at two-week and one-month visits

Study Arms (3)

Experimental BHVI2 eye drops

ACTIVE COMPARATOR

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

Drug: Experimental BHVI2

0.02% Atropine eye drops

ACTIVE COMPARATOR

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

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.

Combination Product: Combination eye drops

Interventions

Experimental BHVI2 DRUG

Experimental BHVI2 eye drops

Experimental BHVI2 eye drops

Atropine sulfate 0.02% eye drops DRUG

Atropine eye drops

0.02% Atropine eye drops

Combination eye drops COMBINATION_PRODUCT

Combination eye drops with experimental BHVI2 plus 0.02% atropine

Experimental BHVI2 plus 0.02% atropine

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:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Ophthalmology - An Sinh Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (18)

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• 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.

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  PMID: 26826749 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

• 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.

  PMID: 29715053 BACKGROUND

• 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.

  PMID: 26340385 BACKGROUND

• 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.

  PMID: 21963266 BACKGROUND

• 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.

  PMID: 24315293 BACKGROUND

• 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.

  PMID: 16996612 BACKGROUND

• 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.

  PMID: 11401629 BACKGROUND

• 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.

  PMID: 2958765 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

• Syniuta LA, Isenberg SJ. Atropine and bifocals can slow the progression of myopia in children. Binocul Vis Strabismus Q. 2001;16(3):203-8.

  PMID: 11511287 BACKGROUND

• Wu PC, Yang YH, Fang PC. The long-term results of using low-concentration atropine eye drops for controlling myopia progression in schoolchildren. J Ocul Pharmacol Ther. 2011 Oct;27(5):461-6. doi: 10.1089/jop.2011.0027. Epub 2011 Aug 4.

  PMID: 21815829 BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Huy D.M Tran, MD, MSc

  Hai Eye Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study treatments will be labelled as A, B and C at the Pharmacy. The masked study products will then be sent to the study coordinator to dispense
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Children aged between 6 to 13 years old. Myopia with spherical equivalent of -0.50D or worse with cylinder of -2.00D or less

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion: February 2, 2019
• Study Completion: June 30, 2019
• Last Updated: February 12, 2020

Record last verified: 2019-02

Locations

VN (1)