NCT05720754

Temperature on Evaporative Dry Eye

Safety and Efficacy of Heated Artificial Tears Under Practical Conditions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: He Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. Therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.

Detailed description

Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (DQS) ophthalmic solution and heated eye mask (HEM) have been found to be beneficial in reducing signs and symptoms of dry eye. Warm compress therapy temperature of 40 °C to 45 °C have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. While in impact of heat on the ocular surface (OS) has not been extensively studied. Controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. Possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently): * increase in drug diffusivity in the vehicle and/or in the ocular surface * increase in partitioning and diffusion * alteration in the lipid structure * increased local blood flow Therefore, the purpose of this RCT is to assess the impact of instilling 3% DQS ophthalmic solution follow by HEM raising the OS temperature by 40 degrees centigrade for 10 minutes.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Diquafosol tetrasodium	3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
DEVICE	Heated eye mask	Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms

Timeline

• Start date: 2023-04-02
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: China