Ocular HypertensionNCT04442464
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
A study testing Scleral Lens in people with Ocular Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- Scleral Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 27 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ocular hypertension (IOP >22 in each eye during at least two visits over the previous 3 years)
- May have had cataract extraction and intraocular lens (IOL)
- Not on topical medication for glaucoma
- No History of ALT/SLT
- Any Age, 18 years or older
- History of contact lens wear (except scleral lenses), as long as they are willing to not wear their lenses the day of the study
Who cannot join
- On topical medication for glaucoma
- Eye disease
- Inability to wear scleral lenses
- Any intraocular surgery other than uncomplicated cataract extraction.
- Known allergy to proparacaine eye drops
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.
Read the detailed description
This is a randomized, self-controlled study designed to compare effectiveness of a scleral lens on intraocular pressure. In this study, all participants have one eye randomly selected to wear the scleral lenses during study measurements and the other eye serves as the control, non-lens wearing eye.
- Conditions
- Ocular Hypertension
- Being tested
- Scleral Lens
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scleral LensDevice
15.0 mm diagnostic spherical rigid contact lens
| Study group | Role | What they receive |
|---|---|---|
| Study Eye | Experimental | One eye will be randomly selected to wear the scleral lenses to be worn during study measurements Receives: Device: Scleral Lens |
| Control Eye | No intervention | Non-lens wearing eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Intraocular pressure measured in millimeters of mercury (mm Hg)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Why it stopped: Lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherie B. Nau, Mayo Clinic
- Investigators
- Cherie Nau, OD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442464
- Sponsor's protocol ID
- 18-004974
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2020
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
- ClinicalTrials.gov ID
- NCT04442464
- Acronym / sponsor ID
- 18-004974
- Conditions
- Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.
Detailed description
This is a randomized, self-controlled study designed to compare effectiveness of a scleral lens on intraocular pressure. In this study, all participants have one eye randomly selected to wear the scleral lenses during study measurements and the other eye serves as the control, non-lens wearing eye.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Eye | Experimental | Device: Scleral LensOne eye will be randomly selected to wear the scleral lenses to be worn during study measurements |
| Control Eye | No intervention | –Non-lens wearing eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of ocular hypertension (IOP >22 in each eye during at least two visits over the previous 3 years)
- May have had cataract extraction and intraocular lens (IOL)
- Not on topical medication for glaucoma
- No History of ALT/SLT
- Any Age, 18 years or older
Key exclusion criteria (5 listed)
- On topical medication for glaucoma
- Eye disease
- Inability to wear scleral lenses
- Any intraocular surgery other than uncomplicated cataract extraction.
- Known allergy to proparacaine eye drops
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 |
|---|---|---|
| Scleral Lens15.0 mm diagnostic spherical rigid contact lens | Device | Study Eye |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 4 hours
Intraocular pressure measured in millimeters of mercury (mm Hg)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cherie Nau, OD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scleral Lens in people with Ocular Hypertension, run by Mayo Clinic 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Apr 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (IOP) (time frame: 4 hours). 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 29 Apr 2024.