Dry EyeNCT06748768
The Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease
An observational study of Dry Eye, run by Superior University at 1 site in Pakistan.
Trial summary
dry eye disease is a common condition characterized by tear film instability and ocular surface inflammation. Omega 3 fatty acid and hot compression are two common tratement for dry eye diseases Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- group 1
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: to check the he Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease
Who may be able to join
- Young adults (20-39) years diagnosed with dry eyes and willingness to participate with no ocular surgery and infection from last 2 weeks Children
Who cannot join
- People having supplements
- Patients having diet with omega 3 for 1 month
- Patients who has undergone glaucoma treatment
- Already receiving treatment of dry eyes
- Patients with any ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
dry eye disease is a common condition characterized by tear film instability and ocular surface inflammation. Omega 3 fatty acid and hot compression are two common tratement for dry eye diseases
Read the detailed description
to investigate the cost effective and efficient treatment for dry eye diseases, During regular visit of patient assessment will be carried out to diagnose disease ,ocular findings and cause of visit .
- Conditions
- Dry Eye
- Being tested
- group 1
- 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.
group 1Diagnostic test
To determine the optimal treatment for dry eyes in term of cost effectiveness and time efficiency by comparing omega 3 supplements versus warm compression
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
The OSDI score was grouped as per the following: normal (0-12 points), mild (13-22 points), moderate (23-32 points), and severe (33-100 points) [7]. Grouping for the number of years smoking was done in the following way: < 1 year, 1-5 years, 6-10 years, 11-15 years, 16-20 years, and 20+ years.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748768
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/043
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06748768
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/043
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
dry eye disease is a common condition characterized by tear film instability and ocular surface inflammation. Omega 3 fatty acid and hot compression are two common tratement for dry eye diseases
Detailed description
to investigate the cost effective and efficient treatment for dry eye diseases, During regular visit of patient assessment will be carried out to diagnose disease ,ocular findings and cause of visit .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- to check the he Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease
Key inclusion criteria (1 listed)
- Young adults (20-39) years diagnosed with dry eyes and willingness to participate with no ocular surgery and infection from last 2 weeks Children
Key exclusion criteria (5 listed)
- People having supplements
- Patients having diet with omega 3 for 1 month
- Patients who has undergone glaucoma treatment
- Already receiving treatment of dry eyes
- Patients with any ocular surgery
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 |
|---|---|---|
| group 1To determine the optimal treatment for dry eyes in term of cost effectiveness and time efficiency by comparing omega 3 supplements versus warm compression | Diagnostic test | – |
Primary outcome
OSDI
Time frame: 12 Months
The OSDI score was grouped as per the following: normal (0-12 points), mild (13-22 points), moderate (23-32 points), and severe (33-100 points) [7]. Grouping for the number of years smoking was done in the following way: < 1 year, 1-5 years, 6-10 years, 11-15 years, 16-20 years, and 20+ years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Superior University 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: 12 Months). 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 27 Dec 2024.