AmblyopiaPhase 1/2CASNCT02594358
Caffeine in Amblyopia Study
A Phase 1/2 study testing Caffeine in people with Amblyopia, run by Johns Hopkins University at 1 site in United States.
Trial summary
Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Amblyopia from strabismus and amblyopia
Who cannot join
- Known intolerance to caffeine
- Diagnosis and/or treatment of attention deficit/hyperactivity disorder
- Presence of an ocular cause for reduced visual acuity
- Myopia with a special equivalent -6.00 diopters
- Current vision therapy or orthoptics - any type
- Ocular cause for reduced visual acuity
Show all 15Show fewer
- Prior intraocular or refractive surgery
- History of narrow-angle glaucoma
- Strabismus surgery planned within 16 weeks
- Nystagmus per se does not exclude the subject if the above visual acuity criteria are met
- Known skin reactions to patch or bandage adhesives
- Known allergy or intolerance to food dyes
- Current treatment with topical atropine eyedrops
- Menarche, pregnancy or lactation
- Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole
Trial locations and contacts
1 site in 1 country.
About this study
Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).
Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.
Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.
Demonstrate recruitment potential of subjects to participate in a dietary intervention study.
- Conditions
- Amblyopia
- Being tested
- Caffeine
- Keywords
- Caffeine
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
| Study group | Role | What they receive |
|---|---|---|
| Caffeine 20 mg | Active comparator | Patching plus once daily caffeine for 12 weeks Receives: Drug: Caffeine |
| Caffeine 40 mg | Active comparator | Patching plus once daily caffeine for 12 weeks Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Quantitative improvement in high resolution visual acuity measured at 3 meters
Measured: 12 weeks
Secondary outcomes (1)
Questionnaire
A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Could not recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Repka, Johns Hopkins University
- Investigators
- Michael X Repka, MD, MBA, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594358
- Sponsor's protocol ID
- NA_00066787
- Acronym
- CAS
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine in Amblyopia Study
- ClinicalTrials.gov ID
- NCT02594358
- Acronym / sponsor ID
- CAS / NA_00066787
- Conditions
- Amblyopia
- Keywords
- Caffeine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).
Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.
Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.
Demonstrate recruitment potential of subjects to participate in a dietary intervention study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine 20 mg | Active comparator | Drug: CaffeinePatching plus once daily caffeine for 12 weeks |
| Caffeine 40 mg | Active comparator | Drug: CaffeinePatching plus once daily caffeine for 12 weeks |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Amblyopia from strabismus and amblyopia
Key exclusion criteria (15 listed)
- Known intolerance to caffeine
- Diagnosis and/or treatment of attention deficit/hyperactivity disorder
- Presence of an ocular cause for reduced visual acuity
- Myopia with a special equivalent -6.00 diopters
- Current vision therapy or orthoptics - any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING | Drug | Caffeine 20 mg, Caffeine 40 mg |
Primary outcome
Visual acuity
Time frame: 12 weeks
Quantitative improvement in high resolution visual acuity measured at 3 meters
1 secondary outcome
Questionnaire
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael X Repka, MD, MBA study chair
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Caffeine in people with Amblyopia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.