NCT04965974

Brief Summary

The study is conducted to evaluate the efficacy of digital blue light blocking filter in improvement of clinical indices of dry eye and ocular symptoms related to dry eye. Introduction: Dry eye disease is a multifactorial disease of the ocular surface caused by loss of tear film homeostasis resulting damage to the ocular surface and neurosensory abnormalities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

Same day

First QC Date

June 10, 2021

Last Update Submit

July 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • tear break up time

    improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.

    8 weeks

  • Schirmer test values

    improvement in aqueous deficient dry eye by Schirmer test values in mm .

    8 weeks

  • corneal surface staining

    'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use

    8 weeks

Secondary Outcomes (1)

  • ocular surface disease index questionnaire

    8 weeks

Study Arms (2)

1 blue light blocking filter group

EXPERIMENTAL

digital blue light blocking filter is installed laptops and mobile phones of 80 individual using digital devices more than 4 hours. asked them to use the filter continuously while using digital devices.

Device: Digital blue light blocking filter

2 non filter users

EXPERIMENTAL

Effect of time duration of digital screen on the dry eyes is checked.

Device: Digital blue light blocking filter

Interventions

digital blue light blocking filter will be given to 80 dry eye subjects in mobile phones and laptops and 80 individuals will be without filters digital devices users

Also known as: F.lux and blue light filter Night mode,Night shift
1 blue light blocking filter group2 non filter users

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe tendency of dry eye disease is more in females .
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females with age 20-35years
  • using digital devices androids and laptops
  • Ametropia of up to 1.0 Diopter sphere(DS) and astigmatism of less than 0.5
  • Emmetropes.

You may not qualify if:

  • Subjects using topical drugs
  • Smokers
  • Subjects undergoing dry eye treatment
  • History of contact lens wear within the past three months
  • Corneal surface disease other than dry eye
  • Corneal or eyelid infections
  • Corneal surgeries
  • Refractive error of more than 1 DS of SE and astigmatism of greater than0.5DC
  • Age \<18 and \>3 years
  • Subjects already using blue light blocking filters
  • I phone users
  • Pregnant women
  • Males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The university of Faisalabad

Faisalābad, Punjab Pakistan, 38000, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Komal Atta, mbbs

CONTACT

Nimra Gul, m.phil od

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The digital blue light blocking filter will be randomly installed in digital devices of the 80 subjects and rest of 80 will be without filter.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 10, 2021

First Posted

July 16, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations