NCT07110467

Brief Summary

The study aimed to evaluate the effect of blinking exercises in improving eye dryness and daily life in older adults. Participants aged 60 years and older of both genders, diagnosed with dry eyes and patients who were alert and able to communicate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 18, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in quality of life

    Impact Dry Eye Everyday Life Questionnaire it include 3 domains (daily activity limitations, emotional wellbeing, and work limitations), a scale score is calculated between 0 (representing total impairment) and 100 (representing no impairment). The daily activities sub-domain is the quality of life instrument. It is comprised of 27 items, each item had five answers "strongly agree" is scored as 1, "agree" is scored as 2, "neutral" is scored as 3, "disagree" is scored as 4, and "strongly disagree" is scored as 5. The greater score indicate high quality of life.

    4 weeks following the end of treatment

Study Arms (2)

blinking excelsis group

EXPERIMENTAL

The study group were divided into small training groups with 3-5 older adult for each group. Two sessions were needed for each group each session took about 1- 2hrs. • The 1st session included (definition, causes, signs \& symptoms, risk factors, complications, prevention, and management of eye dryness and the 2nd session covered the recommended exercises for reducing eye dryness including (Eye gaze exercise, Right and left eye movement exercise, eye rise and fall exercise, eye-crossing exercise, eye control exercise, eye pressure exercise, eye rotation exercise, and eye relaxation exercise). This group was instructed to instill artificial tears and perform blinking exercises three- five times a day for 4 weeks.

Procedure: blinking exercises

control group

SHAM COMPARATOR

this group receive moisturizing eye drop only

Procedure: blinking exercises

Interventions

The study group was instructed to instill artificial tears and perform blinking exercises three- five times a day for 4 weeks.

blinking excelsis groupcontrol group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 years and older of both genders, diagnosed with dry eyes and patients who were alert and able to communicate.

You may not qualify if:

  • Patients underwent refractive surgery procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norther Private Colleague of Nursing

Arar, Norther Border, 1447, Saudi Arabia

Location

Related Links

Study Officials

  • Mostafa Assistance professor, phd

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the participants divided into two group experimental and placebo group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 7, 2025

Study Start

November 1, 2024

Primary Completion

May 2, 2025

Study Completion

June 12, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations