Clinical trial NCT03690414: Evaluation of Short Term Use of Experimental Eye Drops BHVI2, 0.02% Atropine and BHVI2 Plus 0.02% Atropine Eye Drops
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: Myopia control
Atropine eye drops
Caffeine eye drops
Pupillary diameter
Accommodative responses
Lead sponsor: Hai Yen Eye Care
Sponsor class: INDUSTRY
Collaborators: name: Brien Holden Vision
First posted: 2018-10-01
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in pupillary diameter
timeFrame: At baseline, at two-week and one-month visits
measure: Change in accommodative amplitude
timeFrame: At baseline, at two-week and one-month visits
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Department of Ophthalmology - An Sinh Hospital
Study officials:
affiliation: Hai Eye Eye Care
name: Huy D.M Tran, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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