Scleral Lens WearersNCT02643095
Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses
A study testing scleral contact lens in people with Scleral Lens Wearers, run by Jennifer Fogt.
Trial summary
This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleral Lens Wearers
- What is being tested?
- scleral contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2016to 31 Aug 2016
- 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
- Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
- The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
- Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).
Who cannot join
- Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
- Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
- Subjects who are participating in any other clinical trial (FDA or other)
About this study
This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.
- Conditions
- Scleral Lens Wearers
- Being tested
- scleral contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scleral contact lensDevice
Scleral contact lens
| Study group | Role | What they receive |
|---|---|---|
| Lens fitting/evaluation | Experimental | This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month. Receives: Device: scleral contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Measured: 1 month after lens is dispensed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start26 Jan 2016
- Primary completion8 Aug 2016
- Study completion31 Aug 2016
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 Scleral Lens WearersStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Fogt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Fogt, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643095
- Sponsor's protocol ID
- 2015W0197
- Status last verified
- Nov 2023
- First submitted
- 28 Dec 2015
- Last updated
- 6 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses
- ClinicalTrials.gov ID
- NCT02643095
- Acronym / sponsor ID
- 2015W0197
- Conditions
- Scleral Lens Wearers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jennifer FogtUniversity, hospital or other
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lens fitting/evaluation | Experimental | Device: scleral contact lensThis study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
- The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
- Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).
Key exclusion criteria (5 listed)
- Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
- Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
- Subjects who are participating in any other clinical trial (FDA or other)
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 contact lensScleral contact lens | Device | Lens fitting/evaluation |
Primary outcome
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Time frame: 1 month after lens is dispensed
Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Questions about this trial
What is this clinical trial studying?
A study testing scleral contact lens in people with Scleral Lens Wearers, run by Jennifer Fogt.
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 5 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: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 13 Sep 2018). 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?
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses (time frame: 1 month after lens is dispensed). 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 6 Dec 2023.