Evaporative Dry EyeNCT06913387
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
A study testing Lipid Based Artificial Tears and Aqueous Based Artificial Tears in people with Evaporative Dry Eye, run by Superior University at 1 site in Pakistan.
Trial summary
This research aimed to compare the effectiveness of a lipid-based artificial tear (Recuro) against an aqueous-based artificial tear (Softeal) in managing EDE symptoms and signs. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Evaporative Dry Eye
- What is being tested?
- Lipid Based Artificial Tears and Aqueous Based Artificial Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (both genders) aged 18-55 years diagnosed with evaporative dry eye (EDE).
- Willingness to adhere to the prescribed treatment regimen (lipid-based or aqueous-based artificial tears).
- Include patients with a history of dry eye symptoms for at least 1-3 months.
- Ocular Surface Disease Index (OSDI) score ≥13, indicating the presence of mild to severe dry eye symptoms.
- Patients with tear break-up time (TBUT) <10 seconds, indicating tear film instability.
Who cannot join
- Use of any topical ophthalmic medications (e.g., lubricants, anti-inflammatory drugs, or cyclosporine) for dry eye within the last 1 month.
- Active ocular infection or inflammation (e.g., conjunctivitis, uveitis).
- History of ocular surgery or trauma within the past 6 months.
- Participants currently wearing contact lenses or those who have worn contact lenses in the past three months.
- Systemic conditions known to impact ocular surface health, such as uncontrolled diabetes, autoimmune disorders, or Sjögren's syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE: A 6 Week RCT
This research aimed to compare the effectiveness of a lipid-based artificial tear (Recuro) against an aqueous-based artificial tear (Softeal) in managing EDE symptoms and signs.
Read the detailed description
This prospective, double-blind, randomized clinical trial was conducted at Mughal Eye Hospital, Lahore. A sample size of 60 participants (30 per group) was determined using G*Power. Participants (18-55 years, both genders) were assigned 1:1 to Recuro or Softeal for 6 weeks using block randomization (block size 4) generated by Research Randomizer. Primary outcomes included OSDI (Ocular Surface Disease Index) and SANDE (Symptom Assessment in Dry Eye) scores; secondary outcomes were Tear Break-Up Time (TBUT), Schirmer's test, and Meibomian gland expression.
- Conditions
- Evaporative Dry Eye
- Being tested
- Lipid Based Artificial Tears, Aqueous Based Artificial Tears
- 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.
Lipid Based Artificial TearsCombination product
30 participants received lipid-based artificial tears (Recuro) in this study arm. The intervention involved the administration of RECURO EYE DROPS, which contain Sodium carboxymethylcellulose 0.5%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period.
Aqueous Based Artificial TearsCombination product
30 participants received aqueous-based artificial tears (Softeal) in this study arm. The intervention involved the administration of SOFTEAL EYE DROPS, which contain Hydroxypropylmethyl Cellulose 0.3%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period.
| Study group | Role | What they receive |
|---|---|---|
| Lipid Based Artificial Tears | Experimental | Not described Receives: Combination Product: Lipid Based Artificial Tears |
| Aqueous Based Artificial Tears | Experimental | Not described Receives: Combination Product: Aqueous Based Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
Assesses dry eye symptom frequency and impact on vision-related activities. Score ranges from 0-100.
Scoring: 0-12 (Normal), 13-22 (Mild dry eye), 23-32 (Moderate dry eye), ≥ 33 (Severe dry eye).
Measured: 12 Months
SANDE Questionnaire (Symptom Assessment in Dry Eye)
Measures the frequency and severity of dry eye symptoms. Score ranges from 0-100.
Scoring: Higher scores indicate more severe and frequent symptoms
Measured: 12 Months
Meibum Test Score
This score quantifies meibomian gland health and lipid secretion based on meibum quality and expressibility. It is derived from the assessment of 5 central glands in the lower eyelid.
Scoring: Each assessed gland is scored from 0-3, resulting in a total Meibum Test Score for each eye ranging from 0-15.
- Meibum Test Score Key (Per Gland):
- 0: Clear meibum, no blockage (Healthy function)
- 1: Cloudy meibum, mild dysfunction
- 2: Thickened meibum, partial blockage
- 3: No meibum expressed, severe obstruction
- Interpretation: Lower total scores indicate healthier meibomian gland function and better meibum quality/expressibility.
Measured: 12 Months
Tear Break-up Time (TBUT): ( without anesthesia)
Measures tear film stability by observing the time (in seconds) until the first dry spot appears on the cornea after blinking.
Scoring: TBUT <10 seconds is indicative of tear film instability and often associated with dry eye.
Measured: 12 months
Schirmer Test I
Measures tear volume by assessing the length of wetting on a filter paper strip (in millimeters) after 5 minutes, without anesthesia.
Scoring: ≥10 mm (Normal Tear Production),
- 5-9 mm: Mild to Moderate Tear Deficiency (or decreased production), often associated with mild to moderate dry eye
- <5 mm: Severe Tear Deficiency (or significantly decreased production), indicative of severe dry eye
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 Jul 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 Evaporative Dry EyeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06913387
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/792
- Status last verified
- Jul 2025
- First submitted
- 29 Mar 2025
- Last updated
- 15 Jul 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE: A 6 Week RCT
- ClinicalTrials.gov ID
- NCT06913387
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/792
- Conditions
- Evaporative Dry Eye
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jul 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.
This research aimed to compare the effectiveness of a lipid-based artificial tear (Recuro) against an aqueous-based artificial tear (Softeal) in managing EDE symptoms and signs.
Detailed description
This prospective, double-blind, randomized clinical trial was conducted at Mughal Eye Hospital, Lahore. A sample size of 60 participants (30 per group) was determined using G*Power. Participants (18-55 years, both genders) were assigned 1:1 to Recuro or Softeal for 6 weeks using block randomization (block size 4) generated by Research Randomizer. Primary outcomes included OSDI (Ocular Surface Disease Index) and SANDE (Symptom Assessment in Dry Eye) scores; secondary outcomes were Tear Break-Up Time (TBUT), Schirmer's test, and Meibomian gland expression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipid Based Artificial Tears | Experimental | Combination Product: Lipid Based Artificial Tears |
| Aqueous Based Artificial Tears | Experimental | Combination Product: Aqueous Based Artificial Tears |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults (both genders) aged 18-55 years diagnosed with evaporative dry eye (EDE).
- Willingness to adhere to the prescribed treatment regimen (lipid-based or aqueous-based artificial tears).
- Include patients with a history of dry eye symptoms for at least 1-3 months.
- Ocular Surface Disease Index (OSDI) score ≥13, indicating the presence of mild to severe dry eye symptoms.
- Patients with tear break-up time (TBUT) <10 seconds, indicating tear film instability.
Key exclusion criteria (5 listed)
- Use of any topical ophthalmic medications (e.g., lubricants, anti-inflammatory drugs, or cyclosporine) for dry eye within the last 1 month.
- Active ocular infection or inflammation (e.g., conjunctivitis, uveitis).
- History of ocular surgery or trauma within the past 6 months.
- Participants currently wearing contact lenses or those who have worn contact lenses in the past three months.
- Systemic conditions known to impact ocular surface health, such as uncontrolled diabetes, autoimmune disorders, or Sjögren's syndrome.
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 |
|---|---|---|
| Lipid Based Artificial Tears30 participants received lipid-based artificial tears (Recuro) in this study arm. The intervention involved the administration of RECURO EYE DROPS, which contain Sodium carboxymethylcellulose 0.5%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period. | Combination product | Lipid Based Artificial Tears |
| Aqueous Based Artificial Tears30 participants received aqueous-based artificial tears (Softeal) in this study arm. The intervention involved the administration of SOFTEAL EYE DROPS, which contain Hydroxypropylmethyl Cellulose 0.3%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period. | Combination product | Aqueous Based Artificial Tears |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 12 Months
Assesses dry eye symptom frequency and impact on vision-related activities. Score ranges from 0-100. Scoring: 0-12 (Normal), 13-22 (Mild dry eye), 23-32 (Moderate dry eye), ≥ 33 (Severe dry eye).
SANDE Questionnaire (Symptom Assessment in Dry Eye)
Time frame: 12 Months
Measures the frequency and severity of dry eye symptoms. Score ranges from 0-100. Scoring: Higher scores indicate more severe and frequent symptoms
Meibum Test Score
Time frame: 12 Months
This score quantifies meibomian gland health and lipid secretion based on meibum quality and expressibility. It is derived from the assessment of 5 central glands in the lower eyelid. Scoring: Each assessed gland is scored from 0-3, resulting in a total Meibum Test Score for each eye ranging from 0-15. * Meibum Test Score Key (Per Gland): * 0: Clear meibum, no blockage (Healthy function) * 1: Cloudy meibum, mild dysfunction * 2: Thickened meibum, partial blockage * 3: No meibum expressed, severe obstruction * Interpretation: Lower total scores indicate healthier meibomian gland function and better meibum quality/expressibility.
Tear Break-up Time (TBUT): ( without anesthesia)
Time frame: 12 months
Measures tear film stability by observing the time (in seconds) until the first dry spot appears on the cornea after blinking. Scoring: TBUT <10 seconds is indicative of tear film instability and often associated with dry eye.
Schirmer Test I
Time frame: 12 Months
Measures tear volume by assessing the length of wetting on a filter paper strip (in millimeters) after 5 minutes, without anesthesia. Scoring: ≥10 mm (Normal Tear Production), * 5-9 mm: Mild to Moderate Tear Deficiency (or decreased production), often associated with mild to moderate dry eye * <5 mm: Severe Tear Deficiency (or significantly decreased production), indicative of severe dry eye
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 15 Jul 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 Lipid Based Artificial Tears and Aqueous Based Artificial Tears in people with Evaporative 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 5 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 15 Jul 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?
Ocular Surface Disease Index (OSDI) (time frame: 12 Months). The study lists 5 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 15 Jul 2025.