Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye

• Sponsor: Tangible Science (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03417505
• Collaborator: Nova Southeastern University (Other), University of California, Davis (Other), Illinois College of Optometry (Other)
• Enrollment: 21
• Locations: 3
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site: 7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Dry Eye Syndromes	Device: Scleral lenses treated with Tangible Hydra-PEG; Device: Untreated scleral lenses	N/A

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

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, double-masked crossover studyRandomized, double-masked crossover study
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
• Actual Study Start Date: Jan 30, 2018
• Actual Primary Completion Date: Jan 4, 2019
• Actual Study Completion Date: Jan 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treated followed by untreated 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).	Device: Scleral 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.; Other Names: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating ; Device: Untreated scleral lenses; Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.; Other Names: control
Experimental: Untreated followed by treated 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).	Device: Scleral 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.; Other Names: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating ; Device: Untreated scleral lenses; Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.; Other Names: control

Outcome Measures

Primary Outcome Measures

1. Ocular Surface Tear Breakup Time [30 days]

   Tear breakup time of the ocular surface after wearing lenses

2. 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

3. 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).

4. 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 Outcome Measures

1. 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

2. 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.

3. 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.

4. Temporal Conjunctival Lissamine Green Staining [30 days]

   Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).

5. Nasal Conjunctival Lissamine Green Staining [30 days]

   Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis	Sacramento	California	United States	95825
2	Nova Southeastern University	Fort Lauderdale	Florida	United States	33314
3	Illinois College of Optometry	Chicago	Illinois	United States	60616

Sponsors and Collaborators

• Tangible Science
• Nova Southeastern University
• University of California, Davis
• Illinois College of Optometry

Investigators

• Principal Investigator: Chandra Mickles, OD MS FAAO, Nova Southeastern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2018

More Information

Publications

None provided.

• Responsible Party: Tangible Science
• ClinicalTrials.gov Identifier: NCT03417505
• Other Study ID Numbers: STM-0686
• First Posted: Jan 31, 2018
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Tangible Science: Contact lens discomfort; Scleral lens; Tangible Hydra-PEG
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

Participant Flow

Arm/Group Title	Hydra-PEG Treated Lenses Followed by Untreated Lenses	Untreated Lenses Followed by Hydra-PEG Treated Lenses
Arm/Group Description	Hydra-PEG treated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing untreated lenses	Untreated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing Hydra-PEG treated lenses
Period Title: First Lens Type (30 Days)
STARTED	9	12
COMPLETED	8	11
NOT COMPLETED	1	1
Period Title: First Lens Type (30 Days)
STARTED	8	11
COMPLETED	8	11
NOT COMPLETED	0	0
Period Title: First Lens Type (30 Days)
STARTED	8	11
COMPLETED	8	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Participants
Arm/Group Description	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.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.8 (8)
Sex: Female, Male (Count of Participants)
Female	16 84.2%
Male	3 15.8%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Ocular Surface Tear Breakup Time
Description	Tear breakup time of the ocular surface after wearing lenses
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [seconds]	3.81 (2.63)	2.91 (2.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 1 sided
	Comments	Paired t-test comparison

2. Primary Outcome

Title	Corneal Fluorescein Staining
Description	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

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	0.92 (0.79)	1.40 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Calculated p value was <0.05.
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank comparisons, one-sided

3. Primary Outcome

Title	Ocular Surface Disease Index (OSDI) Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

all participants

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [OSDI score]	28.24 (12.90)	35.10 (17.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 1 sided
	Comments	paired 1-sided t-test

4. Primary Outcome

Title	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Description	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

Outcome Measure Data

Analysis Population Description

all participants

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [CLDEQ-8 score]	11.89 (5.26)	17.30 (6.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank comparison, one sided p value

5. Secondary Outcome

Title	Tear Breakup Time Over the Surface of the Scleral Lens
Description	Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

all participants

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [seconds]	5.88 (5.17)	4.75 (2.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Calculated p value was >0.05.
	Method	t-test, 1 sided
	Comments	paired

6. Secondary Outcome

Title	Lid Wiper Epitheliopathy
Description	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

Outcome Measure Data

Analysis Population Description

all participants analyzed with each lens type

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	0.89 (0.76)	1.41 (0.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Calculated p value was <0.05.
	Method	Wilcoxon (Mann-Whitney)
	Comments	paired, 1-sided

7. Secondary Outcome

Title	Contact Lens-related Papillary Conjunctivitis
Description	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

Outcome Measure Data

Analysis Population Description

all participants were analyzed in each lens type

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	0.89 (0.66)	1.45 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	paired, 1-sided

8. Secondary Outcome

Title	Temporal Conjunctival Lissamine Green Staining
Description	Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

all participants analyzed in both lens types

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	0.95 (0.79)	1.23 (1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Calculated p value was <0.05.
	Method	Wilcoxon (Mann-Whitney)
	Comments	paired, 1-sided

9. Secondary Outcome

Title	Nasal Conjunctival Lissamine Green Staining
Description	Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

all participants were analyzed in both lens types

Arm/Group Title	Hydra-PEG Treated Lens Wearers	Untreated Lens Wearers
Arm/Group Description	Patients wearing the Hydra-PEG treated lenses	Patients wearing lenses without the Hydra-PEG treatment
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	0.79 (0.71)	1.03 (0.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydra-PEG Treated Lens Wearers, Untreated Lens Wearers
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Calculated p value was >0.05.
	Method	Wilcoxon (Mann-Whitney)
	Comments	paired, 1-sided

Adverse Events

Time Frame	Adverse event data were collected throughout the period of the study (a period of 79 days for each participant).
Arm/Group Title	Hydra-PEG Treated Lenses Followed by Untreated Lenses		Untreated Lenses Followed by Hydra-PEG Treated Lenses
Arm/Group Description	Participants wore Hydra-PEG lenses for 30 days, followed by a 7 day washout period and then 30 days wearing untreated lenses.		Participants wore untreated lenses for 30 days, followed by a 7 day washout period and then 30 days wearing Hydra-PEG treated lenses.
All Cause Mortality
	Hydra-PEG Treated Lenses Followed by Untreated Lenses		Untreated Lenses Followed by Hydra-PEG Treated Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/12 (0%)
Serious Adverse Events
	Hydra-PEG Treated Lenses Followed by Untreated Lenses		Untreated Lenses Followed by Hydra-PEG Treated Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Hydra-PEG Treated Lenses Followed by Untreated Lenses		Untreated Lenses Followed by Hydra-PEG Treated Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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).