Dry EyeNCT03417505
Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
A study testing Scleral lenses treated with Tangible Hydra-PEG and Untreated scleral lenses in people with Dry Eye and Dry Eye Syndromes, run by Tangible Science at 3 sites in United States.
Trial summary
Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- Scleral lenses treated with Tangible Hydra-PEG and Untreated scleral lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2018to 4 Jan 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort
- Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.
Who cannot join
- Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)
- Anatomic variations of the conjunctiva that can impair proper scleral lens fitting
- Pregnancy
- Best corrected Snellen visual acuity worse than 20/30 in either eye
- Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Illinois College of Optometry
Chicago, Illinois, 60616
Nova Southeastern University
Fort Lauderdale, Florida, 33314
University of California, Davis
Sacramento, California, 95825
About this study
Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.
Read the detailed description
Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact on quality of life. For decades, this condition has presented a challenge to eye care professionals as conventional therapies are often ineffective. Recently, scleral lenses have demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients, inadequate wettability of scleral lenses with subsequent diminished comfort and visual clarity remains a concern for scleral lens wearers with dry eye.
Tangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time, ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable lens wearers, to our knowledge, no clinical research investigation has examined the benefits of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will also be assessed to corroborate our findings.
This will be the first randomized double masked cross-over study to examine CLD and DE symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping with dry eye disease. This study will provide new information about this innovative technology and help practitioners envisage rehabilitative options which will best optimize the quality of life of this important patient population.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Scleral lenses treated with Tangible Hydra-PEG, Untreated scleral lenses
- Keywords
- Contact lens discomfort, Scleral lens, Tangible Hydra-PEG
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scleral lenses treated with Tangible Hydra-PEGDevice
Also called Tangible Hydra-PEG is a hydrophilic PEG-based lens coating
Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.
Untreated scleral lensesDevice
Also called control
Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.
| Study group | Role | What they receive |
|---|---|---|
| Treated followed by untreated | Experimental | Patients wear the Hydra-PEG treated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the untreated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered prior to the control treatment (untreated scleral lenses). Receives: Device: Scleral lenses treated with Tangible Hydra-PEG; Device: Untreated scleral lenses |
| Untreated followed by treated | Experimental | Patients wear the untreated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the Hydra-PEG treated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered after the control treatment (untreated scleral lenses). Receives: Device: Scleral lenses treated with Tangible Hydra-PEG; Device: Untreated scleral lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Tear Breakup Time
Tear breakup time of the ocular surface after wearing lenses
Measured: 30 days
Corneal Fluorescein Staining
Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses
Measured: 30 days
Ocular Surface Disease Index (OSDI) Questionnaire
Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).
Measured: 30 days
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.
Measured: 30 days
Secondary outcomes (5)
Tear Breakup Time Over the Surface of the Scleral Lens
Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens
Measured: 30 days
Lid Wiper Epitheliopathy
Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale to see if there is a change in the height and width of the staining of the lid wiper area with Hydra-PEG treated lenses compared to untreated control lenses. The lid wiper area is the portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface or lens during blinking. Epitheliopathy is scored on a scale from 0 (best patient outcome) to 3 (worst patient outcome, more staining) on the basis of the horizontal and vertical extent of lid margin staining.
Measured: 30 days
Contact Lens-related Papillary Conjunctivitis
Visual inspection for contact lens-related papillary conjunctivitis with scoring by the Efron grading scale for papillary conjunctivitis [0 (normal) to 4 (severe)] to assess changes after wear of Hydra-PEG treated lenses compared to control lenses.
Measured: 30 days
Temporal Conjunctival Lissamine Green Staining
Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).
Measured: 30 days
Nasal Conjunctival Lissamine Green Staining
Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start30 Jan 2018
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-masked crossover study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tangible Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University, University of California, Davis, Illinois College of Optometry
- Responsible party
- Sponsor
- Investigators
- Chandra Mickles, OD MS FAAO, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417505
- Sponsor's protocol ID
- STM-0686
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2018
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Mickles CV, Harthan JS, Barnett M. Assessment of a Novel Lens Surface Treatment for Scleral Lens Wearers With Dry Eye. Eye Contact Lens. 2021 May 1;47(5):308-313. doi: 10.1097/ICL.0000000000000754.
PubMed 33156128
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
- ClinicalTrials.gov ID
- NCT03417505
- Acronym / sponsor ID
- STM-0686
- Conditions
- Dry Eye, Dry Eye Syndromes
- Keywords
- Contact lens discomfort, Scleral lens, Tangible Hydra-PEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tangible ScienceIndustry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University, University of California, Davis, Illinois College of Optometry
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.
Detailed description
Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact on quality of life. For decades, this condition has presented a challenge to eye care professionals as conventional therapies are often ineffective. Recently, scleral lenses have demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients, inadequate wettability of scleral lenses with subsequent diminished comfort and visual clarity remains a concern for scleral lens wearers with dry eye.
Tangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time, ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable lens wearers, to our knowledge, no clinical research investigation has examined the benefits of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will also be assessed to corroborate our findings.
This will be the first randomized double masked cross-over study to examine CLD and DE symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping with dry eye disease. This study will provide new information about this innovative technology and help practitioners envisage rehabilitative options which will best optimize the quality of life of this important patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, double-masked crossover study
| Arm | Type | Receives |
|---|---|---|
| Treated followed by untreated | Experimental | Device: Scleral lenses treated with Tangible Hydra-PEG, Device: Untreated scleral lensesPatients wear the Hydra-PEG treated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the untreated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered prior to the control treatment (untreated scleral lenses). |
| Untreated followed by treated | Experimental | Device: Scleral lenses treated with Tangible Hydra-PEG, Device: Untreated scleral lensesPatients wear the untreated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the Hydra-PEG treated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered after the control treatment (untreated scleral lenses). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort
- Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.
Key exclusion criteria (5 listed)
- Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)
- Anatomic variations of the conjunctiva that can impair proper scleral lens fitting
- Pregnancy
- Best corrected Snellen visual acuity worse than 20/30 in either eye
- Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.
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 lenses treated with Tangible Hydra-PEGAlso: Tangible Hydra-PEG is a hydrophilic PEG-based lens coatingScleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time. | Device | Treated followed by untreated, Untreated followed by treated |
| Untreated scleral lensesAlso: controlScleral lenses without the Tangible Hydra-PEG treatment will serve as a control. | Device | Treated followed by untreated, Untreated followed by treated |
Primary outcome
Ocular Surface Tear Breakup Time
Time frame: 30 days
Tear breakup time of the ocular surface after wearing lenses
Corneal Fluorescein Staining
Time frame: 30 days
Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses
Ocular Surface Disease Index (OSDI) Questionnaire
Time frame: 30 days
Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: 30 days
Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.
5 secondary outcomes
Tear Breakup Time Over the Surface of the Scleral Lens
Time frame: 30 days
Lid Wiper Epitheliopathy
Time frame: 30 days
Contact Lens-related Papillary Conjunctivitis
Time frame: 30 days
Temporal Conjunctival Lissamine Green Staining
Time frame: 30 days
Nasal Conjunctival Lissamine Green Staining
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33156128Mickles CV, Harthan JS, Barnett M. Assessment of a Novel Lens Surface Treatment for Scleral Lens Wearers With Dry Eye. Eye Contact Lens. 2021 May 1;47(5):308-313. doi: 10.1097/ICL.0000000000000754.
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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.
Chandra Mickles, OD MS FAAO principal investigator
Nova Southeastern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scleral lenses treated with Tangible Hydra-PEG and Untreated scleral lenses in people with Dry Eye and Dry Eye Syndromes, run by Tangible Science at 3 sites 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 2 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 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 18 Jan 2020). 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?
Ocular Surface Tear Breakup Time (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417505, which also lists 1 linked publication.
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 2020.