Trial Outcomes & Findings for Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye (NCT NCT03417505)

Results Overview

Tear breakup time of the ocular surface after wearing lenses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

30 days

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
First Lens Type (30 Days) STARTED	9	12
First Lens Type (30 Days) COMPLETED	8	11
First Lens Type (30 Days) NOT COMPLETED	1	1
Washout Period (7 Days) STARTED	8	11
Washout Period (7 Days) COMPLETED	8	11
Washout Period (7 Days) NOT COMPLETED	0	0
Second Lens Type (30 Days) STARTED	8	11
Second Lens Type (30 Days) COMPLETED	8	11
Second Lens Type (30 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
First Lens Type (30 Days) Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=19 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.
Age, Continuous	51.8 years STANDARD_DEVIATION 8 • n=19 Participants
Sex: Female, Male Female	16 Participants n=19 Participants
Sex: Female, Male Male	3 Participants n=19 Participants

PRIMARY outcome

Timeframe: 30 days

Tear breakup time of the ocular surface after wearing lenses

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Ocular Surface Tear Breakup Time	3.81 seconds Standard Deviation 2.63	2.91 seconds Standard Deviation 2.14

PRIMARY outcome

Timeframe: 30 days

Population: All participants

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

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Corneal Fluorescein Staining	0.92 score on a scale Standard Deviation 0.79	1.40 score on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: 30 days

Population: all participants

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).

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Ocular Surface Disease Index (OSDI) Questionnaire	28.24 OSDI score Standard Deviation 12.90	35.10 OSDI score Standard Deviation 17.60

PRIMARY outcome

Timeframe: 30 days

Population: all participants

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.

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)	11.89 CLDEQ-8 score Standard Deviation 5.26	17.30 CLDEQ-8 score Standard Deviation 6.50

SECONDARY outcome

Timeframe: 30 days

Population: all participants

Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Tear Breakup Time Over the Surface of the Scleral Lens	5.88 seconds Standard Deviation 5.17	4.75 seconds Standard Deviation 2.82

SECONDARY outcome

Timeframe: 30 days

Population: all participants analyzed with each lens type

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.

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Lid Wiper Epitheliopathy	0.89 score on a scale Standard Deviation 0.76	1.41 score on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: 30 days

Population: all participants were analyzed in each lens type

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.

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Contact Lens-related Papillary Conjunctivitis	0.89 score on a scale Standard Deviation 0.66	1.45 score on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: 30 days

Population: all participants analyzed in both lens types

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

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Temporal Conjunctival Lissamine Green Staining	0.95 score on a scale Standard Deviation 0.79	1.23 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 30 days

Population: all participants were analyzed in both lens types

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

Outcome measures

Outcome measures
Measure	Hydra-PEG Treated Lens Wearers n=19 Participants Patients wearing the Hydra-PEG treated lenses	Untreated Lens Wearers n=19 Participants Patients wearing lenses without the Hydra-PEG treatment
Nasal Conjunctival Lissamine Green Staining	0.79 score on a scale Standard Deviation 0.71	1.03 score on a scale Standard Deviation 0.98

Adverse Events

Hydra-PEG Treated Lenses Followed by Untreated Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untreated Lenses Followed by Hydra-PEG Treated Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kelly Mabry

Tangible Science

Phone: 650-241-1045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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).
Publication restrictions are in place

Restriction type: OTHER