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

Hai Yen Eye Care

Status and phase: Completed; Phase 1

Conditions: Myopia

Treatments: Combination Product: Combination eye drops; Drug: Atropine sulfate 0.02% eye drops; Drug: Experimental BHVI2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03690414

VCRTC-2018-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups

Experimental BHVI2 eye drops

Active Comparator group

Description:

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

Treatment:

Drug: Experimental BHVI2

0.02% Atropine eye drops

Active Comparator group

Description:

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

Treatment:

Drug: Atropine sulfate 0.02% eye drops

Experimental BHVI2 plus 0.02% atropine

Active Comparator group

Description:

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

Treatment:

Combination Product: Combination eye drops