Irregular; Contour of CorneaNCT03612284
Scleral Contact Lens Insertion Solution Study
A study testing contact lens insertion solution in people with Irregular; Contour of Cornea, run by Jennifer Fogt at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irregular; Contour of Cornea
- What is being tested?
- contact lens insertion solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 30 Nov 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older.
- Wear a scleral contact lens habitually 6 or more hours a day.
- Needs to remove scleral lens due to fogging and refill or definitely reports fogging.
- Must have worn habitual scleral lens for at least 3 months
- Willing and able to attend study visits.
Who cannot join
- Currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. Stable keratoconus is acceptable.
- Currently taking topical ophthalmic prescription medications.
- Current medical eye complications such as glaucoma or uveitis.
- Recent corneal surgery
- Sjogrens or other clinically significant active ocular surface disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.
Read the detailed description
The sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. The initial exposure - filling the posterior bowl of the scleral contact lens by the Investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work.
This is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. The (historical) control is the saline habitually used by the subjects.
The sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials.
The primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. The primary efficacy outcome will be ocular comfort as assessed by questionnaire.
- Conditions
- Irregular; Contour of Cornea
- Being tested
- contact lens insertion solution
- Keywords
- Contact lens solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact lens insertion solutionDevice
This contact lens solution is being tested for safety and comfort and is not an "intervention." Subjects will have their scleral contact lenses filled with the test saline in the examination room and applied to their eyes. They will be monitored for symptoms and will be examined. Six to 8 hours later or whenever their lens clouding typically occurs they will return for further assessment and dispensing of solution if acceptable. subjects will use the solution for 5-9 days and return for a follow-up appointment. At each visit, subjects will complete an OSDI questionnaire and a Current Symptoms questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility | Experimental | Scleral lens insertion solution study. This is not an interventional study, but a study to test a new contact lens solution. Primary FDA Classification: 21 CFR 886.5928 Soft (Hydrophilic) Contact Lens Care Products Product Code: LPN
Secondary FDA Classification: 21 CFR 886.5918 - Rigid gas permeable contact lens care products Product Code: MRC
The FDA has previously made risk determinations (class II, non-significant risk) for devices classified under 21 CFR 886.5928 and 21 CFR 886.5918. As a non-significant risk device, the GatorFil Contact Lens Saline Solution is exempt from the IDE regulation (21 CFR 812). Receives: Device: contact lens insertion solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal staining or corneal disruption as assessed with clinical biomicroscope
ocular safety examination
Measured: immediately after first use of solution and again in 5 to 9 days
Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire
Subjects will answer the OSDI questionnairre (score of 0-48) used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
Measured: 5 to 9 days
Comfort as assessed by Current Symptoms Survey (CSS)
Subjects will respond to the CSS survey (scores of 0-100 for various symptoms) - used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
Measured: 5 to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start27 Nov 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular; Contour of CorneaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Fogt
- Sponsor type
- University, hospital or other
- Collaborators
- Contamac Ltd
- Responsible party
- Sponsor-investigator, Jennifer Fogt, Ohio State University
- Investigators
- Jennifer Fogt, OD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612284
- Sponsor's protocol ID
- 2017H0141
- Status last verified
- Jan 2019
- First submitted
- 4 Jun 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Contact Lens Insertion Solution Study
- ClinicalTrials.gov ID
- NCT03612284
- Acronym / sponsor ID
- 2017H0141
- Conditions
- Irregular; Contour of Cornea
- Keywords
- Contact lens solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jennifer FogtUniversity, hospital or other
- Collaborators
- Contamac Ltd
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 Aug 2018 (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.
The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.
Detailed description
The sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. The initial exposure - filling the posterior bowl of the scleral contact lens by the Investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work.
This is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. The (historical) control is the saline habitually used by the subjects.
The sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials.
The primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. The primary efficacy outcome will be ocular comfort as assessed by questionnaire.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility | Experimental | Device: contact lens insertion solutionScleral lens insertion solution study. This is not an interventional study, but a study to test a new contact lens solution. Primary FDA Classification: 21 CFR 886.5928 Soft (Hydrophilic) Contact Lens Care Products Product Code: LPN Secondary FDA Classification: 21 CFR 886.5918 - Rigid gas permeable contact lens care products Product Code: MRC The FDA has previously made risk determinations (class II, non-significant risk) for devices classified under 21 CFR 886.5928 and 21 CFR 886.5918. As a non-significant risk device, the GatorFil Contact Lens Saline Solution is exempt from the IDE regulation (21 CFR 812). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older.
- Wear a scleral contact lens habitually 6 or more hours a day.
- Needs to remove scleral lens due to fogging and refill or definitely reports fogging.
- Must have worn habitual scleral lens for at least 3 months
- Willing and able to attend study visits.
Key exclusion criteria (5 listed)
- Currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. Stable keratoconus is acceptable.
- Currently taking topical ophthalmic prescription medications.
- Current medical eye complications such as glaucoma or uveitis.
- Recent corneal surgery
- Sjogrens or other clinically significant active ocular surface disease.
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 |
|---|---|---|
| contact lens insertion solutionThis contact lens solution is being tested for safety and comfort and is not an "intervention." Subjects will have their scleral contact lenses filled with the test saline in the examination room and applied to their eyes. They will be monitored for symptoms and will be examined. Six to 8 hours later or whenever their lens clouding typically occurs they will return for further assessment and dispensing of solution if acceptable. subjects will use the solution for 5-9 days and return for a follow-up appointment. At each visit, subjects will complete an OSDI questionnaire and a Current Symptoms questionnaire. | Device | Device Feasibility |
Primary outcome
Change in corneal staining or corneal disruption as assessed with clinical biomicroscope
Time frame: immediately after first use of solution and again in 5 to 9 days
ocular safety examination
Comfort and vision quality as assessed by Ocular Surface Disease Index (OSDI) questionnaire
Time frame: 5 to 9 days
Subjects will answer the OSDI questionnairre (score of 0-48) used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
Comfort as assessed by Current Symptoms Survey (CSS)
Time frame: 5 to 9 days
Subjects will respond to the CSS survey (scores of 0-100 for various symptoms) - used to assess symptoms related to comfort and vision. The survey will be done with the subjects regular solution and repeated after using the test solution
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 18 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Irregular; Contour of Cornea
RecruitingObservational study
Scleral Lens Fitting Using Wide-Field OCT
Keratoconus, Irregular; Contour of Cornea
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.
Jennifer Fogt, OD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contact lens insertion solution in people with Irregular; Contour of Cornea, run by Jennifer Fogt 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 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 18 Jan 2019. 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?
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?
Change in corneal staining or corneal disruption as assessed with clinical biomicroscope (time frame: immediately after first use of solution and again in 5 to 9 days). The study lists 3 primary outcomes in all. 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 18 Jan 2019.