Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Condition: Dry Eye; Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

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.
    

Intervention name(s): Scleral lenses treated with Tangible Hydra-PEG; Untreated scleral lenses
Intervention type(s): Device; Device
Intervention description(s): 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.; Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.
Other intervention name(s): Tangible Hydra-PEG is a hydrophilic PEG-based lens coating; control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-masked crossover study
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Contact lens discomfort; Scleral lens; Tangible Hydra-PEG