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

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ClinicalTrials.gov Identifier: NCT03690414
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Brien Holden Vision
Information provided by (Responsible Party):
Hai Yen Eye Care

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.

Condition or disease Intervention/treatment Phase
Myopia Drug: Experimental BHVI2 Drug: Atropine sulfate 0.02% eye drops Combination Product: Combination eye drops Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Other
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
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : February 2, 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental BHVI2 eye drops
20 participants will receive one drop per eye every night for four weeks.
Drug: Experimental BHVI2
Experimental BHVI2 eye drops

Active Comparator: 0.02% Atropine eye drops
20 participants will receive one drop per eye every night for four weeks.
Drug: Atropine sulfate 0.02% eye drops
Atropine eye drops

Active Comparator: Experimental BHVI2 plus 0.02% atropine
20 participants will receive one drop per eye every night for four weeks.
Combination Product: Combination eye drops
Combination eye drops with experimental BHVI2 plus 0.02% atropine




Primary Outcome Measures :
  1. 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

  2. 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



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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:

  • 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.

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): NCT03690414


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
Investigators
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Principal Investigator: Huy D.M Tran, MD, MSc Hai Eye Eye Care

Publications:

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Responsible Party: Hai Yen Eye Care
ClinicalTrials.gov Identifier: NCT03690414     History of Changes
Other Study ID Numbers: VCRTC-2018-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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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:
Myopia control
Atropine eye drops
Caffeine eye drops
Pupillary diameter
Accommodative responses
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Ophthalmic Solutions
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action