Dry Eye, Dry Eye Syndromes
Conditions
Keywords
Contact lens discomfort, Scleral lens, Tangible Hydra-PEG
Brief 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 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.
Interventions
DEVICEScleral lenses treated with Tangible Hydra-PEG
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.
DEVICEUntreated scleral lenses
Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.
Sponsors
Nova Southeastern University
University of California, Davis
Illinois College of Optometry
Tangible Science
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Randomized, double-masked crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Tear Breakup Time | 30 days | Tear breakup time of the ocular surface after wearing lenses |
| Corneal Fluorescein Staining | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Breakup Time Over the Surface of the Scleral Lens | 30 days | Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens |
| Nasal Conjunctival Lissamine Green Staining | 30 days | Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining). |
| Lid Wiper Epitheliopathy | 30 days | 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. |
| Contact Lens-related Papillary Conjunctivitis | 30 days | 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. |
| Temporal Conjunctival Lissamine Green Staining | 30 days | Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Lens Type (30 Days) | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Participants | — |
|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 0 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
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.
Time frame: 30 days
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) | 11.89 CLDEQ-8 score | Standard Deviation 5.26 |
| Untreated Lens Wearers | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) | 17.30 CLDEQ-8 score | Standard Deviation 6.5 |
p-value: <0.01Wilcoxon (Mann-Whitney)
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
Time frame: 30 days
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Corneal Fluorescein Staining | 0.92 score on a scale | Standard Deviation 0.79 |
| Untreated Lens Wearers | Corneal Fluorescein Staining | 1.40 score on a scale | Standard Deviation 1.05 |
p-value: <0.05Wilcoxon (Mann-Whitney)
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).
Time frame: 30 days
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Ocular Surface Disease Index (OSDI) Questionnaire | 28.24 OSDI score | Standard Deviation 12.9 |
| Untreated Lens Wearers | Ocular Surface Disease Index (OSDI) Questionnaire | 35.10 OSDI score | Standard Deviation 17.6 |
p-value: <0.01t-test, 1 sided
Primary
Ocular Surface Tear Breakup Time
Tear breakup time of the ocular surface after wearing lenses
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Ocular Surface Tear Breakup Time | 3.81 seconds | Standard Deviation 2.63 |
| Untreated Lens Wearers | Ocular Surface Tear Breakup Time | 2.91 seconds | Standard Deviation 2.14 |
p-value: <0.01t-test, 1 sided
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.
Time frame: 30 days
Population: all participants were analyzed in each lens type
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Contact Lens-related Papillary Conjunctivitis | 0.89 score on a scale | Standard Deviation 0.66 |
| Untreated Lens Wearers | Contact Lens-related Papillary Conjunctivitis | 1.45 score on a scale | Standard Deviation 0.51 |
p-value: <0.01Wilcoxon (Mann-Whitney)
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.
Time frame: 30 days
Population: all participants analyzed with each lens type
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Lid Wiper Epitheliopathy | 0.89 score on a scale | Standard Deviation 0.76 |
| Untreated Lens Wearers | Lid Wiper Epitheliopathy | 1.41 score on a scale | Standard Deviation 0.62 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Nasal Conjunctival Lissamine Green Staining
Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).
Time frame: 30 days
Population: all participants were analyzed in both lens types
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Nasal Conjunctival Lissamine Green Staining | 0.79 score on a scale | Standard Deviation 0.71 |
| Untreated Lens Wearers | Nasal Conjunctival Lissamine Green Staining | 1.03 score on a scale | Standard Deviation 0.98 |
p-value: >0.05Wilcoxon (Mann-Whitney)
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
Time frame: 30 days
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Tear Breakup Time Over the Surface of the Scleral Lens | 5.88 seconds | Standard Deviation 5.17 |
| Untreated Lens Wearers | Tear Breakup Time Over the Surface of the Scleral Lens | 4.75 seconds | Standard Deviation 2.82 |
p-value: >0.05t-test, 1 sided
Secondary
Temporal Conjunctival Lissamine Green Staining
Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).
Time frame: 30 days
Population: all participants analyzed in both lens types
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydra-PEG Treated Lens Wearers | Temporal Conjunctival Lissamine Green Staining | 0.95 score on a scale | Standard Deviation 0.79 |
| Untreated Lens Wearers | Temporal Conjunctival Lissamine Green Staining | 1.23 score on a scale | Standard Deviation 1.03 |
p-value: <0.05Wilcoxon (Mann-Whitney)