Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06016166

Enrollment

Registered

2023-08-29

Start date

2023-10-01

Completion date

2024-12-01

Last updated

2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on sleep quality and tear layer function in patients with dry eye disease. In this regard, a total of 34 patients with dry eye disease aged between 20 to 35 years old will be participated. They will be randomly divided into case and control (n=17) groups. Patients in the case group will be instructed to wear the eye mask as long as two weeks and the controls will be recommended to not wear it at the same time. Afterwards, the eye mask application will be cross- over for the next 2 hours between the two groups. Tear layer will be investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep quality will be checked by the PSQI test.

Interventions

DEVICEEye mask

The 3D eye mask with the ability to adjust for different faces and eliminate light

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients with dry eye disease according to the OSDI test

Exclusion criteria

* Patients with eye disease except dry eye * Patients using systemic and ophthalmic drugs * Patients using sleeping and sedative pills

Design outcomes

Primary

Measure	Time frame	Description
The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye	between baseline and follow- ups of weeks 2 and 4	Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test
The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye	between baseline and follow- ups of weeks 2 and 4	Sleep quality is measured by PSQI test based on the obtained score

Countries

Iran

Contacts

Primary ContactHamideh Sabbaghi, PhD

sabbaghi.opt@gmail.com989120285930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026