Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Phase: NA
Conditions: Dry Eye, Dry Eye Syndromes
Sponsor: Tangible Science

                                                                                                              
 
 
  
 
 
Title of Project: Tangible Hydra-PegTM: A Promising Solution for Scleral Lens  
    Wearers with Dry Eye 
 
Investigators:  
P.I. Chandra Mickles, OD, MS, FAAO, FSLS  
(Nova Southeastern University College of Optometry) 
Melissa Barnett, OD, FAAO, FSLS (University of California, Davis Eye Center) 
Jennifer Harthan, OD, FAAO, FSLS (Illinois College of Optometry) 
 
Abstract:  
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.1-5 
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 TM (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, 6-7 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 as 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. 
NCT03417505
rev date: 1/30/2018

                                                                                                              
 
Specific Aims:  
1. The primary goal of this study is to compare the CLD and DE symptoms of moderate to 
severe DE subjects between 30 days of Tangible Hydra-Peg treated scleral lens wear and 
30 days of untreated scleral lens wear.  
Hypothesis: CLD and DE symptoms will be significantly better after 30 days of Hydra-
Peg treated scleral lens wear as compared to 30 days of untreated scleral lens wear. 
 
2. The secondary goal of this study is compare the CLD and DE signs of moderate to severe 
DE subjects between 30 days of Tangible Hydra-Peg treated scleral lens wear and 30 
days of untreated scleral lens wear in DE subjects. As DE can impact vision quality and 
Hydra-Peg may impact contact lens wearing times, as a subanalysis, we will also 
examine  contact lens wearing times and quality of vision such as frequency of foggy 
vision between treated and untreated scleral lens wear. 
Hypothesis: CLD and DE signs will be significantly better after 30 days of Hydra-Peg 
treated scleral lens wear as compared to 30 days of untreated scleral lens wear. Frequency 
of foggy vision and contact lens wearing time will be significantly better after 30 days of 
Hydra-Peg treated scleral lens wear as compared to 30 days of untreated scleral lens 
wear.  
 
Methods: 
Participant Recruitment 
In a multi-center randomized double-masked cross-over study, 30 scleral lens wearers with CLD 
and moderate to severe DE shall be recruited for a non-significant risk 1-month study. 
Participants will be enrolled at three geographically diverse academic site locations across North 
America (Fort Lauderdale, FL, Chicago, Illinois, and Sacramento, CA). The participants  will be 
randomly selected from those exhibiting CLD and moderate to severe symptomatic dryness as 
determined by the validated and commonly used Ocular Surface Disease Index (OSDI) dry eye 
questionnaire (Appendix A) and the validated Contact Lens Dry Eye Questionnaire-8 (CLDEQ-
8) (Appendix B). These symptom surveys are recommended to be included in a clinical study 
assessing DE and CLD by expert researchers of the International Dry Eye Workshop and the 
International Workshop on Contact Lens Discomfort respectively.8, 9   The participants will be 18 
to 70 years of age and have the presence of reduced tear film break up time (TBUT), a sign of 
DE and CLD.8.9  
A participant will be defined as a scleral lens wearer if he or she reports wearing his or her lenses 
at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer 
than 1 year. Due to the widely varying parameters of scleral lenses and lens diameter having an 
impact on comfort, in this study scleral lens wear will be defined as 15.0 mm to 19.00 mm 
inclusive. All participants will be required to remain in primarily the same scleral lens 

                                                                                                              
parameters including material throughout the study, except for the change in lens coating. Except 
for the wash-out periods, all subjects will be required to continue with the same supportive dry 
eye therapy and use hydrogen peroxide for lens care throughout the study.  
Participants with the following will be excluded from this study: disorders that affect sensitivity 
(herpetic disease, severe diabetes mellitus), anatomic variations of the conjunctiva that can 
impair proper scleral lens fitting, pregnancy, and significant visual impairment that could 
confound the results of the study which, for the purposes of this study, will be defined as best 
corrected Snellen visual acuity worse than 20/30 in either eye or any other ocular pathology (e.g. 
glaucoma, macular degeneration, keratoconus) other than DE, which may significantly impact 
visual function.  
Experimental Design 
30 subjects with symptomatic moderate to severe dry eye and symptoms of CLD will complete a 
double-masked cross-over study. The participants will be randomly chosen to wear their habitual 
untreated scleral lenses or Hydra-Peg treated scleral lenses first for 30 days. Half of the 
participants (15) will be randomly chosen to wear the Hydra-Peg treated scleral lenses first for 
30 days, and the other half of the participants (15) will be chosen to wear their habitual untreated 
scleral lenses for 30 days first. One week wash-out periods with no lens wear will be placed 
before and between the 30-day test periods. The OSDI, CLDEQ-8, a battery of  dry eye 
diagnostic tests, and tests which will assess the impact of contact lenses on the ocular surface 
will be administered from 3:00 to 5:00 pm at baseline, after the first test period, and after the 
cross-over. Contact lens wearing time and questions related to quality of vision will also be 
collected at baseline, after the first test period, and after the cross-over. 
The battery of clinical dry eye sensitive tests will include, TBUT of the ocular surface, and 
ocular surface staining. TBUT over the surface of the scleral lenses, lid wiper epitheliopathy 
(LWE), and contact lens-related papillary conjunctivitis we will also be examined as they these 
factors may change with alteration of a contact lens surface.   
The study will be double-masked. Lens pairs will be supplied in identical cases, differing only by 
code mark unknown to the tester. Only one lens pair during the respective test period (treated or 
untreated) will be given to each participant. The general study schedule following recruitment is 
described below. 
 
 
 
 
 
 
 

                                                                                                              
General Study Schedule 
To obtained informed consent  
Day 1   
                     Screening 
1)  Informed Consent, HIPAA 
authorization 
2) OSDI and CLDEQ-8  
              3) Assessment of TBUT 
Days 1-8  (1 week)  
               Wash-out period 
Days 9   
   Baseline Testing  
(1) OSDI, CLEDEQ-8, additional questions 
(skip questions 3 and 5)  
(2) Battery of Clinical tests 
(3) Randomization of lenses 
Days 9-39  (30 days)  
                      
 Test Period 1  
Wear of treated or untreated CL 
Day 40 
Post CL Wear Testing  
(1) OSDI, CLDEQ-8, additional questions 
 (2)  Battery of Clinical Tests 
Day 40-47  (1 week)  
  1  week Wash-out Period 
Days 48-78 ( 30 days)  
Test Period 2  
Wear of treated or untreated CL 
Day  79    
Post CL Wear Testing 
(1) OSDI, CLDEQ-8, additional questions 
(2) Battery of Clinical Tests 
 
 
 
Data Collection: 
Data will be kept primarily electronically through REDCap, a secure database application 
designed to support data capture for research studies. The data will be collected on encrypted and 
password protected electronic devices. An electronic and hard copy versions of the OSDI and 
CLDEQ-8 will be available. The hard copy of the questionnaires will be used only if the secure 
web link or server is not functioning. As soon as the server is functioning, the data from the 
paper survey will be uploaded to REDCap. The battery of clinical tests will be completed on a 
form which will be uploaded to REDCap. All data will be de-identified other than by code. The 
study data will be reviewed by Tangible Science, LLC, and members of this study team only.  
 

                                                                                                              
Statistical Analysis 
The key values used for analysis in this study will be differences in CLD and DE 
symptoms following scleral lens wear with Tangible Hydra-Peg and that found after untreated 
scleral lens wear. In addition, we will examine differences in CLD and DE signs between 
Tangible Hydra-Peg scleral lens wear and untreated scleral lens wear. Preliminary data analyses 
will include inspection for kurtosis and skewness of each distribution and test for normality, 
using the Shapiro-Wilk test. Normal distributions will be analyzed using a paired t-test. Non-
normal distributions will be analyzed with the Wilcoxon Signed Ranked test.  
 
References Cited: 
 
1. Weber SL, de Souza RB, Gomes JA, Hofling-Lima AL.  The use of Esclera Scleral Contact 
Lens in the treatment of moderate to severe dry eye disease. Am J Ophthalmol. 2016 Mar; 
163: 167-73.  
 
2. Yuksel E, Bilgihan K, Novruzlu S, Yuksel N, Koksal M.  The management of refractory dry 
eye with a semi-scleral contact lens. Eye Contact Lens. 2016 May; 0:1-3. 
 
3. van der Worp E. A Guide to Scleral Lens Fitting, Version 2.0 [monograph online]. Forest  
Grove, OR: Pacific University; 2015. Available from: 
http://commons.pacificu.edu/mono/10/. 
4. Alipour F, Kheirkhah A, Behrouz M. Use of mini-scleral contact lenses in moderate to severe 
dry eye. Cont Lens Anterior Eye. 2012 Dec; 35(6):272-6. 
 
5. Schornack M, Pyle J, and Patel S. Scleral lenses in the management of ocular surface disease. 
Ophthalmology. 2014; 121:1398-1405. 
 
6. Caroline, P. et al. “Hydra-PEG: A Solution to Contact Lens Discomfort?” Poster presented at 
Global Specialty Lens Symposium 2015 
 
7. Sindt, C. “Evaluation Polyethylene Glycol Surface Coating on Gas Permeable Lenses to 
Improve Wearability and Wettability.” Poster presented at Annual Meeting of the 
Association for Research in Vision and Ophthalmology 2016 (poster # 1462−A0142). 
 
8. Nichols JJ, Willcox MD, Bron AJ, Belmonte C, Ciolino JB, Craig JP, Dogru M, Foulks GN, 
Jones L, Nelson JD, Nichols KK, Purslow C, Schaumberg DA, Stapleton F, Sullivan DA; 
members of The TFOS International Workshop on Contact Lens Discomfort. The TFOS 
International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol 
Vis Sci. 2013 Oct 18; 54(11):TFOS7−TFOS13. 
 
9. No Authors Listed (2007) Report of the International Dry Eye Workshop (DEWS). Ocular 
Surface 5(2):65-204