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Myopia Control With Novel Eye Drops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04301323
Recruitment Status : Active, not recruiting
First Posted : March 10, 2020
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
Brien Holden Vision Institute
Information provided by (Responsible Party):
Hai Yen Eye Care

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.


Condition or disease Intervention/treatment Phase
Myopia Drug: BHVI1 eye drops Drug: BHVI2 eye drops Drug: BHVI3 eye drops Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: A Two-year, Randomized, Single-centre, Double-masked, Comparative Study to Evaluate the Annual Rate of Myopia Progression of Children With Myopia Receiving Daily BHVI1, BHVI2 Eye Drops Either Alone or in Combination
Actual Study Start Date : October 26, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BHVI1
BHVI1 eye drops
Drug: BHVI1 eye drops
Including 35 children enrolled to receive BHVI1 eye-drops once nightly
Other Name: Novel BHVI1 eye drops

Experimental: BHVI2
BHVI2 eye drops
Drug: BHVI2 eye drops
Including 35 children enrolled to receive BHVI2 eye-drops once nightly
Other Name: Novel BHVI2 eye drops

Experimental: BHVI3
Combination of BHVI1 and BHVI2 eye drops
Drug: BHVI3 eye drops
Including 35 children enrolled to receive BHVI3, combination of BHVI1 and BHVI2, eye-drops once nightly
Other Name: Novel BHVI3 eye drops

No Intervention: Non-randomized control group
a separate control group including 105 children enrolled and followed with only single-vision spectacles.



Primary Outcome Measures :
  1. Spherical equivalent [ Time Frame: at baseline visit, at one-year and two-year visits ]
    Annual change in spherical equivalent from baseline


Secondary Outcome Measures :
  1. Axial length [ Time Frame: at baseline visit, at one-year and two-year visits ]
    Annual change in axial length from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Subjects enrolled in the trial must:

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301323


Locations
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Vietnam
Department of Ophthalmology - An Sinh Hospital
Ho Chi Minh City, Vietnam, 700000
Sponsors and Collaborators
Hai Yen Eye Care
Brien Holden Vision Institute
Investigators
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Study Director: Padmaja Sankaridurg, Professor Brien Holden Vision Institute; School of Optometry and Vision Science - University of New South Wales
Additional Information:
Publications:

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Responsible Party: Hai Yen Eye Care
ClinicalTrials.gov Identifier: NCT04301323    
Other Study ID Numbers: CS/AS/18/12
VCRTC-2018-02 ( Other Identifier: HYEC-BHVI )
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data would be available 6 months after the study ends and the study group could finalise the data analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hai Yen Eye Care:
Atropine
Combination eye drops
Myopia control
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions