Dry Eye SyndromeNCT06913556
Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP
A study testing Preoperative dry eyes and Lipid coated carbomer gel eye drops in people with Dry Eye Syndrome, run by Superior University at 1 site in Pakistan.
Trial summary
In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked. In research, the randomized control trial methodology is used Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Preoperative dry eyes and Lipid coated carbomer gel eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 50-70
- Both gender male /female
Who cannot join
- Patients who have acute dry eye condition before phacoemulsification cataract surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in Diabetic Patients
In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked. In research, the randomized control trial methodology is used
- Conditions
- Dry Eye Syndrome
- Being tested
- Preoperative dry eyes, Lipid coated carbomer gel eye drops
- 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.
Preoperative dry eyesDiagnostic test
In group 1 we access preoperative dry eyes condition and postoperatively we access the condition in 2nd and 4th week with the use of Hylorunic acid lubricant.
Lipid coated carbomer gel eye dropsCombination product
In group 2 we prescribe the lipid coated carbomer gel eye drops and access dry eyes condition preoperative and postoperative on 2nd and 4th week and check the curative effect of drop.
| Study group | Role | What they receive |
|---|---|---|
| preoperative dry eyes | Experimental | Not described Receives: Diagnostic Test: Preoperative dry eyes |
| lipid coated carbomer gel eye drops | Experimental | Not described Receives: Combination Product: Lipid coated carbomer gel eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Tear Break-Up Time (TBUT) test
The Tear Break-Up Time (TBUT) test measures how long the tear film on the eye surface remains intact before it breaks up, with a normal TBUT typically being 10 seconds or more. A shorter TBUT suggests tear film instability and potential dry eye issues.
Measured: 12 Months
Schirmer test
In a Schirmer test, a score of greater than 10 mm of moistened area on the filter paper after 5 minutes is considered normal, while less than 10 mm suggests dry eyes
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 posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT06913556
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/807
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06913556
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/807
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked. In research, the randomized control trial methodology is used
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative dry eyes | Experimental | Diagnostic Test: Preoperative dry eyes |
| lipid coated carbomer gel eye drops | Experimental | Combination Product: Lipid coated carbomer gel eye drops |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 50-70
- Both gender male /female
Key exclusion criteria (1 listed)
- Patients who have acute dry eye condition before phacoemulsification cataract 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 |
|---|---|---|
| Preoperative dry eyesIn group 1 we access preoperative dry eyes condition and postoperatively we access the condition in 2nd and 4th week with the use of Hylorunic acid lubricant. | Diagnostic test | preoperative dry eyes |
| Lipid coated carbomer gel eye dropsIn group 2 we prescribe the lipid coated carbomer gel eye drops and access dry eyes condition preoperative and postoperative on 2nd and 4th week and check the curative effect of drop. | Combination product | lipid coated carbomer gel eye drops |
Primary outcome
The Tear Break-Up Time (TBUT) test
Time frame: 12 Months
The Tear Break-Up Time (TBUT) test measures how long the tear film on the eye surface remains intact before it breaks up, with a normal TBUT typically being 10 seconds or more. A shorter TBUT suggests tear film instability and potential dry eye issues.
Schirmer test
Time frame: 12 Months
In a Schirmer test, a score of greater than 10 mm of moistened area on the filter paper after 5 minutes is considered normal, while less than 10 mm suggests dry eyes
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 6 Apr 2025.
- 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 Preoperative dry eyes and Lipid coated carbomer gel eye drops in people with Dry Eye Syndrome, 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 2 inclusion and 1 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 6 Apr 2025. 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?
The Tear Break-Up Time (TBUT) test (time frame: 12 Months). The study lists 2 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 6 Apr 2025.