MyopiaPhase 4NCT03158142
The Influence of Atropine on Choroidal Thickness
A Phase 4 study testing Atropine Sulfate 1% Oph Soln in people with Myopia, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate 1% Oph Soln
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 20 Nov 2017
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general and ocular health
- Soft contact lens wearers to cease lens wear for at least 24 hours
- No previous rigid gas permeable lens wear
Who cannot join
- History of ocular surgery, including refractive surgery
- Amblyopia
- Use of ocular medications
- Known allergies or sensitivity to atropine
- Pregnant, plan to become pregnant, or are breastfeeding
- Taking monoamine oxidase inhibitors (MAOIs)
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York College of Optometry
New York, New York, 10036
About this study
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects.
The aim of this study is to characterize the effects of atropine on choroidal thickness and the influence of time of administration (am vs pm). It is hypothesized that the atropine's effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm, where thicker baseline thickness will show a reduced choroidal response.
Read the detailed description
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. The choroid shows diurnal variation and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown. Thus, the objective of this study is to provide data to characterize the influence of atropine on choroid thickness. The study aims are to:
- Determine the effect of am or pm atropine application on choroid thickness
- Determine the effect of atropine on choroid thickness in relationship to baseline thickness
Participants will be asked to attend a screening session and 13 study visits. Following the screening visit, participants will be scheduled to return for 4 visits across 12 hours (4 hour intervals starting from 8am) in a single day where eye shape measurements will be taken to characterize diurnal variations in eye shape.
Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in the morning or a night. Measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week washout period, 1% atropine eye drops will be administered either in the morning or at night (the visit that was not previously scheduled) and measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate 1% Oph Soln
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine Sulfate 1% Oph SolnDrug
Also called 1% atropine eye drops
Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic
| Study group | Role | What they receive |
|---|---|---|
| Atropine group | Experimental | One drop of Atropine Sulfate 1% Oph Soln will be administered either in the morning or at night in each eye. Study measurements will be taken approximately after 1, 12, 24 and 96 hours after drop instillation. After a 2 week wash out period with no eye drops, another drop of 1% atropine sulfate ophthalmic eye drops will be administered either in the morning or night (the visit that was not taken before) and study measurements will be scheduled approximately after 1, 12 24 and 96 hours after drop instillation Receives: Drug: Atropine Sulfate 1% Oph Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Change in choroidal thickness after atropine
Measured: Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Mar 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158142
- Sponsor's protocol ID
- 1000533-1
- Status last verified
- Oct 2018
- First submitted
- 16 May 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD collected from the study will be made available to other the investigators that have been listed on this study. IPD will be de-identified before making it available to the other investigators. IPD will become available after the end of study data collection. Deidentified IPD will be obtained by other investigator in excel files sent by the primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Atropine on Choroidal Thickness
- ClinicalTrials.gov ID
- NCT03158142
- Acronym / sponsor ID
- 1000533-1
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects.
The aim of this study is to characterize the effects of atropine on choroidal thickness and the influence of time of administration (am vs pm). It is hypothesized that the atropine's effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm, where thicker baseline thickness will show a reduced choroidal response.
Detailed description
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. The choroid shows diurnal variation and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown. Thus, the objective of this study is to provide data to characterize the influence of atropine on choroid thickness. The study aims are to:
- Determine the effect of am or pm atropine application on choroid thickness
- Determine the effect of atropine on choroid thickness in relationship to baseline thickness
Participants will be asked to attend a screening session and 13 study visits. Following the screening visit, participants will be scheduled to return for 4 visits across 12 hours (4 hour intervals starting from 8am) in a single day where eye shape measurements will be taken to characterize diurnal variations in eye shape.
Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in the morning or a night. Measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week washout period, 1% atropine eye drops will be administered either in the morning or at night (the visit that was not previously scheduled) and measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atropine group | Experimental | Drug: Atropine Sulfate 1% Oph SolnOne drop of Atropine Sulfate 1% Oph Soln will be administered either in the morning or at night in each eye. Study measurements will be taken approximately after 1, 12, 24 and 96 hours after drop instillation. After a 2 week wash out period with no eye drops, another drop of 1% atropine sulfate ophthalmic eye drops will be administered either in the morning or night (the visit that was not taken before) and study measurements will be scheduled approximately after 1, 12 24 and 96 hours after drop instillation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general and ocular health
- Soft contact lens wearers to cease lens wear for at least 24 hours
- No previous rigid gas permeable lens wear
Key exclusion criteria (6 listed)
- History of ocular surgery, including refractive surgery
- Amblyopia
- Use of ocular medications
- Known allergies or sensitivity to atropine
- Pregnant, plan to become pregnant, or are breastfeeding
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 |
|---|---|---|
| Atropine Sulfate 1% Oph SolnAlso: 1% atropine eye dropsAtropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic | Drug | Atropine group |
Primary outcome
Choroidal thickness
Time frame: Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation
Change in choroidal thickness after atropine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No. All IPD collected from the study will be made available to other the investigators that have been listed on this study. IPD will be de-identified before making it available to the other investigators. IPD will become available after the end of study data collection. Deidentified IPD will be obtained by other investigator in excel files sent by the primary investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine Sulfate 1% Oph Soln in people with Myopia, run by State University of New York College of Optometry 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Oct 2018. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Choroidal thickness (time frame: Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation). 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 15 Oct 2018.