Dry Eye DiseaseNCT04965974
Efficacy of Blue Wavelength in Managing Dry Eye
A study testing Digital blue light blocking filter in people with Dry Eye Disease, run by University of Faisalabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Digital blue light blocking filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The university of Faisalabad
Faisalābad, Punjab Pakistan, 38000
Nimra Gul, M.phil, 0315 66773622, Nimra.gul@tuf.edu.pk
Komal Atta, mbbs, 03224075007, komal.atta@tuf.edu.pk
About this study
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.
Read the detailed description
60 subjects aged 20-35 years with ocular surface disease index score greater than 13 will be taken from the University of Faisalabad. After taking consent, procedure starts from history then Schirmer test 1 will be performed to measure the tear deficient dry eye. Tear break up time will be done to assess the evaporative dry eye. Corneal surface staining will be used to measure corneal erosions. OSDI questionnaire will be used for the evaluation of ocular symptoms related to dry eye. 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. After baseline data follow ups will be after 3 weeks and second after 8 weeks of filter use. Schirmer test 1, tear break up time corneal surface staining and OSDI will be performed on both groups (filter users and non-filter users) for the evaluation of dry eye. Data will be analyzed using SPSS version 21. Result of this study will give knowledge that use of digital blue light blocking filters are useful in the management of dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- Digital blue light blocking filter
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital blue light blocking filterDevice
Also called F.lux and blue light filter Night mode,Night shift
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Digital blue light blocking filter |
| 2 non filter users | Experimental | Effect of time duration of digital screen on the dry eyes is checked. Receives: Device: Digital blue light blocking filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear break up time
improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.
Measured: 8 weeks
Schirmer test values
improvement in aqueous deficient dry eye by Schirmer test values in mm .
Measured: 8 weeks
corneal surface staining
'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use
Measured: 8 weeks
Secondary outcomes (1)
ocular surface disease index questionnaire
improvement in ocular surface disease index score.13-22ocular surface disease index score mild dry eye ,23-32 score means moderate dry eye and ocular surface disease index greater than 33 indicate severe dry eye .
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumaila Masood, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965974
- Sponsor's protocol ID
- TUF/MPO/2101
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Blue Wavelength in Managing Dry Eye
- ClinicalTrials.gov ID
- NCT04965974
- Acronym / sponsor ID
- TUF/MPO/2101
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
60 subjects aged 20-35 years with ocular surface disease index score greater than 13 will be taken from the University of Faisalabad. After taking consent, procedure starts from history then Schirmer test 1 will be performed to measure the tear deficient dry eye. Tear break up time will be done to assess the evaporative dry eye. Corneal surface staining will be used to measure corneal erosions. OSDI questionnaire will be used for the evaluation of ocular symptoms related to dry eye. 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. After baseline data follow ups will be after 3 weeks and second after 8 weeks of filter use. Schirmer test 1, tear break up time corneal surface staining and OSDI will be performed on both groups (filter users and non-filter users) for the evaluation of dry eye. Data will be analyzed using SPSS version 21. Result of this study will give knowledge that use of digital blue light blocking filters are useful in the management of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1 blue light blocking filter group | Experimental | Device: Digital blue light blocking filterdigital 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. |
| 2 non filter users | Experimental | Device: Digital blue light blocking filterEffect of time duration of digital screen on the dry eyes is checked. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital blue light blocking filterAlso: F.lux and blue light filter Night mode,Night shiftdigital 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 | Device | 1 blue light blocking filter group, 2 non filter users |
Primary outcome
tear break up time
Time frame: 8 weeks
improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.
Schirmer test values
Time frame: 8 weeks
improvement in aqueous deficient dry eye by Schirmer test values in mm .
corneal surface staining
Time frame: 8 weeks
'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use
1 secondary outcome
ocular surface disease index questionnaire
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital blue light blocking filter in people with Dry Eye Disease, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Komal Atta, mbbs (03224075007, komal.atta@tuf.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tear break up time (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.