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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690414
• Other study ID #: VCRTC-2018-01
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2019
• Source: Hai Yen Eye Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 eye drops.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 30, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Experimental BHVI2
Experimental BHVI2 eye drops
• Atropine sulfate 0.02% eye drops
Atropine eye drops

Combination Product:
• Combination eye drops
Combination eye drops with experimental BHVI2 plus 0.02% atropine

Locations

Country	Name	City	State
Vietnam	Department of Ophthalmology - An Sinh Hospital	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Hai Yen Eye Care	Brien Holden Vision

Country where clinical trial is conducted

Vietnam, 

References & Publications (18)

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. — View Citation

Chatzistefanou KI, Mills MD. The role of drug treatment in children with strabismus and amblyopia. Paediatr Drugs. 2000 Mar-Apr;2(2):91-100. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):391-9. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11. — View Citation

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. Epub 2006 Sep 25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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