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

February 11, 2020 updated by: Hai Yen Eye Care

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Department of Ophthalmology - An Sinh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, at two-week and one-month visits
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
At baseline, at two-week and one-month visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hai Yen Eye Care

Collaborators

Brien Holden Vision

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

February 2, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCRTC-2018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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