Dry EyeNCT06390644
Effect of Periorbital Massage on Dry Eye Disease
A study testing Periorbital Massage Therapy in people with Dry Eye, run by Superior University at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Periorbital Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Symptoms of dry eye (such as burning, dryness or foreign body sensation)
- Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)
- Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol
Who cannot join
- Active ocular infection
- Ocular surgery within past 3 months
- Use of contact lenses
- Use of systemic medications that can affect tear production or tear quality
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home
Lahore, Punjab Province
About this study
This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.
Read the detailed description
Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.
- Conditions
- Dry Eye
- Being tested
- Periorbital Massage Therapy, Control Group (Standard Care)
- 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.
Periorbital Massage TherapyDiagnostic test
Participants in this arm will receive periorbital massage therapy administered by a trained practitioner. The massage technique will involve gentle circular motions around the eye sockets and brow bone area, aiming to improve eyelid and tear gland function.
Control Group (Standard Care)Other
Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy."
| Study group | Role | What they receive |
|---|---|---|
| Periorbital Massage Therapy | Experimental | Participants in this arm will receive periorbital massage therapy administered by a trained practitioner. Receives: Diagnostic Test: Periorbital Massage Therapy |
| Control Group (Standard Care) | Other | Participants in this arm will receive standard care for dry eye disease. Receives: Other: Control Group (Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer Strips
Schirmer's test is used to determine whether the eye produces enough tears to keep it moist. The test is performed by placing filter paper inside the lower lid of the eye. After 5 minutes, the paper is removed and tested for its moisture content.
Measured: 12 Months
Secondary outcomes (1)
OSDI Questionnaire
The Ocular Surface Disease Index (OSDI) is a questionnaire that has been validated to discriminate between normal, mild to moderate, and severe dry eye disease as defined by the physician's assessment and a composite disease severity score
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 posted30 Apr 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion30 Sep 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06390644
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/701
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periorbital Massage on Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06390644
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/701
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Apr 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.
This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.
Detailed description
Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periorbital Massage Therapy | Experimental | Diagnostic Test: Periorbital Massage TherapyParticipants in this arm will receive periorbital massage therapy administered by a trained practitioner. |
| Control Group (Standard Care) | Other | Other: Control Group (Standard Care)Participants in this arm will receive standard care for dry eye disease. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Symptoms of dry eye (such as burning, dryness or foreign body sensation)
- Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)
- Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol
Key exclusion criteria (5 listed)
- Active ocular infection
- Ocular surgery within past 3 months
- Use of contact lenses
- Use of systemic medications that can affect tear production or tear quality
- Pregnancy or lactation
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 |
|---|---|---|
| Periorbital Massage TherapyParticipants in this arm will receive periorbital massage therapy administered by a trained practitioner. The massage technique will involve gentle circular motions around the eye sockets and brow bone area, aiming to improve eyelid and tear gland function. | Diagnostic test | Periorbital Massage Therapy |
| Control Group (Standard Care)Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy." | Other | Control Group (Standard Care) |
Primary outcome
Schirmer Strips
Time frame: 12 Months
Schirmer's test is used to determine whether the eye produces enough tears to keep it moist. The test is performed by placing filter paper inside the lower lid of the eye. After 5 minutes, the paper is removed and tested for its moisture content.
1 secondary outcome
OSDI Questionnaire
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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?
A study testing Periorbital Massage Therapy in people with 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 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 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?
Results are not available in the source record.
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?
Schirmer Strips (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 30 Apr 2024.