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| Name | Class |
|---|---|
| Nova Southeastern University | OTHER |
| University of California, Davis | OTHER |
| Illinois College of Optometry | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scleral lenses treated with Tangible Hydra-PEG | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Tear Breakup Time | Tear breakup time of the ocular surface after wearing lenses | 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 | 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). | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Lid Wiper Epitheliopathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandra Mickles, OD MS FAAO | Nova Southeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95825 | United States | ||
| Nova Southeastern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33156128 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydra-PEG Treated Lenses Followed by Untreated Lenses | Hydra-PEG treated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing untreated lenses |
| FG001 | Untreated Lenses Followed by Hydra-PEG Treated Lenses | Untreated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing Hydra-PEG treated lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Lens Type (30 Days) |
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| Washout Period (7 Days) |
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| Second Lens Type (30 Days) |
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All participants wore both the Hydra-PEG treated and untreated lenses in this crossover study, therefore the baseline characteristics are the same for both lens types.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | As this was a crossover study, all participants work both the Hydra-PEG treated and untreated lenses. Therefore, the baseline characteristics were the same for both groups. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Surface Tear Breakup Time | Tear breakup time of the ocular surface after wearing lenses | Posted | Mean | Standard Deviation | seconds | 30 days |
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Adverse event data were collected throughout the period of the study (a period of 79 days for each participant).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydra-PEG Treated Lenses Followed by Untreated Lenses | Participants wore Hydra-PEG lenses for 30 days, followed by a 7 day washout period and then 30 days wearing untreated lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Mabry | Tangible Science | 650-241-1045 | 108 | kelly@tangiblescience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2018 | Dec 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Randomized, double-masked crossover study
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| Untreated scleral lenses | Device | Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control. |
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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.
| 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. | 30 days |
| Temporal Conjunctival Lissamine Green Staining | Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining). | 30 days |
| Nasal Conjunctival Lissamine Green Staining | Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining). | 30 days |
| Fort Lauderdale |
| Florida |
| 33314 |
| United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | 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 | All participants | Posted | Mean | Standard Deviation | score on a scale | 30 days |
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| Primary | 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). | all participants | Posted | Mean | Standard Deviation | OSDI score | 30 days |
|
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| Primary | 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. | all participants | Posted | Mean | Standard Deviation | CLDEQ-8 score | 30 days |
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| Secondary | 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 | all participants | Posted | Mean | Standard Deviation | seconds | 30 days |
|
|
|
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| Secondary | 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. | all participants analyzed with each lens type | Posted | Mean | Standard Deviation | score on a scale | 30 days |
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| Secondary | 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. | all participants were analyzed in each lens type | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
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| Secondary | Temporal Conjunctival Lissamine Green Staining | Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining). | all participants analyzed in both lens types | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
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| Secondary | Nasal Conjunctival Lissamine Green Staining | Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining). | all participants were analyzed in both lens types | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
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|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Untreated Lenses Followed by Hydra-PEG Treated Lenses | Participants wore untreated lenses for 30 days, followed by a 7 day washout period and then 30 days wearing Hydra-PEG treated lenses. | 0 | 12 | 0 | 12 | 0 | 12 |
The PI has the right to publish results from the study. The Sponsor has 30 days to review communications prior to publication with respect to the disclosure of confidential information (study results would not qualify as confidential information).