Dry Eye Disease (DED)Phase 4NCT07635849
Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease
A Phase 4 study testing Carboxy methyl cellulose and Preservative free Carboxy methyl cellulose in people with Dry Eye Disease (DED), run by Pokhara Academy of Health Sciences, Western Regional Hospital at 1 site in Nepal.
Trial summary
Dry Eye Disease (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Carboxy methyl cellulose and Preservative free Carboxy methyl cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNepal
- Study dates
- Jul 2026to Mar 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Clinical diagnosis of Dry Eye Disease (OSDI >13 and TBUT <10 seconds)
- Willingness to provide written informed consent
Who cannot join
- Contact lens use
- Active ocular infection or inflammation
- History of ocular surgery within the past 6 months
- Use of systemic immunosuppressive therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site
Pokhara Academy of Health Sciences
Pokhara, Gandaki, 33700
Phanindra Prasad Poudel, Msc, PhD, +977-9846115569, poudelpha@gmail.com
Damodar Sharma, MBBS, MD
About this study
Official title: Comparative Effectiveness of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease: A Randomized Clinical Trial
Dry Eye Disease (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro complex (SOC) which may cause ocular surface toxicity with long-term use. Preservative-free artificial tears are considered safer alternatives, but comparative clinical evidence from Nepal is limited. This study aims to compare the clinical efficacy and safety of preservative-free versus preserved carboxymethylcellulose (CMC) artificial tears in patients with Dry Eye Disease. This will be a hospital-based, randomized, double-blinded controlled clinical trial conducted in the ophthalmology outpatient department of a tertiary care hospital in Nepal. A total of 80 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive either preservative-free CMC artificial tears or preserved CMC artificial tears for a duration of eight weeks. Participant, investigators, outcome assessors and data analysts will remain blinded to minimize assessment bias. Baseline assessments will include the Ocular Surface Disease Index (OSDI) questionnaire, Tear Film Break-Up Time (TBUT), Schirmer's test (without anesthesia), and corneal fluorescein staining. These outcomes will be reassessed at four and eight weeks. Safety and tolerability will be evaluated by documenting patient-reported adverse effects. Data will be analyzed using appropriate statistical methods, with a p-value of less than 0.05 considered statistically significant. The study is expected to demonstrate superior safety and improved ocular surface outcomes with preservative-free artificial tears compared to preserved formulations. Findings from this research will provide local evidence to guide rational prescribing practices and improve the management of Dry Eye Disease in Nepal.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Carboxy methyl cellulose, Preservative free Carboxy methyl cellulose
- 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.
Carboxy methyl celluloseDrug
Also called preserved CMC
A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preserved CMC artificial tears for a duration of eight weeks.
Preservative free Carboxy methyl celluloseDrug
Also called preservative-free CMC
A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preservative-free CMC artificial tears for a duration of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DED receiving CMC with preservative | Active comparator | 40 patients will receive drops in the eye Receives: Drug: Carboxy methyl cellulose |
| Patients with DED receiving CMC without preservative | Active comparator | 40 patients will receive drops in the eye Receives: Drug: Preservative free Carboxy methyl cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI) Score
Ocular Surface Disease Index (OSDI) Score. The OSDI is a 12-item questionnaire that assesses dry eye symptoms and their impact on vision-related functioning. Total scores range from a minimum of 0 to a maximum of 100. Higher scores indicate more severe dry eye symptoms and a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
Tear Film Break-Up Time (TBUT)
Tear Film Break-Up Time (TBUT). This measures the time elapsed in seconds between a complete blink and the appearance of the first dry spot on the cornea. It does not have a strict maximum value, but a minimum of 0 seconds. Higher values indicate a more stable tear film and a better outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Schirmer's Test (without anesthesia)
This measures basic tear production by placing a paper strip inside the lower eyelid for 5 minutes. It is measured in millimeters (mm) of wetting, with a minimum of 0 mm and a typical maximum of 35 mm. Higher values indicate better tear production and a better outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Corneal Fluorescein Staining Score
Corneal Fluorescein Staining Score using the Oxford Grading Scheme. This scale assesses the severity of damage to the surface of the eye. The total score ranges from a minimum of 0 to a maximum of 15. Higher scores indicate greater damage to the cornea and a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pokhara Academy of Health Sciences, Western Regional Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Damodar Sharma, Pokhara Academy of Health Sciences, Western Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635849
- Sponsor's protocol ID
- CTRL-DEDCMC-PRVFREE/WITHPRV
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 10 Jun 2026
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07635849
- Acronym / sponsor ID
- CTRL-DEDCMC-PRVFREE/WITHPRV
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pokhara Academy of Health Sciences, Western Regional HospitalOther government
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Jun 2026 (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 (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro complex (SOC) which may cause ocular surface toxicity with long-term use. Preservative-free artificial tears are considered safer alternatives, but comparative clinical evidence from Nepal is limited. This study aims to compare the clinical efficacy and safety of preservative-free versus preserved carboxymethylcellulose (CMC) artificial tears in patients with Dry Eye Disease. This will be a hospital-based, randomized, double-blinded controlled clinical trial conducted in the ophthalmology outpatient department of a tertiary care hospital in Nepal. A total of 80 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive either preservative-free CMC artificial tears or preserved CMC artificial tears for a duration of eight weeks. Participant, investigators, outcome assessors and data analysts will remain blinded to minimize assessment bias. Baseline assessments will include the Ocular Surface Disease Index (OSDI) questionnaire, Tear Film Break-Up Time (TBUT), Schirmer's test (without anesthesia), and corneal fluorescein staining. These outcomes will be reassessed at four and eight weeks. Safety and tolerability will be evaluated by documenting patient-reported adverse effects. Data will be analyzed using appropriate statistical methods, with a p-value of less than 0.05 considered statistically significant. The study is expected to demonstrate superior safety and improved ocular surface outcomes with preservative-free artificial tears compared to preserved formulations. Findings from this research will provide local evidence to guide rational prescribing practices and improve the management of Dry Eye Disease in Nepal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with DED receiving CMC with preservative | Active comparator | Drug: Carboxy methyl cellulose40 patients will receive drops in the eye |
| Patients with DED receiving CMC without preservative | Active comparator | Drug: Preservative free Carboxy methyl cellulose40 patients will receive drops in the eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Clinical diagnosis of Dry Eye Disease (OSDI >13 and TBUT <10 seconds)
- Willingness to provide written informed consent
Key exclusion criteria (4 listed)
- Contact lens use
- Active ocular infection or inflammation
- History of ocular surgery within the past 6 months
- Use of systemic immunosuppressive therapy
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 |
|---|---|---|
| Carboxy methyl celluloseAlso: preserved CMCA total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preserved CMC artificial tears for a duration of eight weeks. | Drug | Patients with DED receiving CMC with preservative |
| Preservative free Carboxy methyl celluloseAlso: preservative-free CMCA total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preservative-free CMC artificial tears for a duration of eight weeks. | Drug | Patients with DED receiving CMC without preservative |
Primary outcome
Ocular Surface Disease Index (OSDI) Score
Time frame: From enrollment to the end of treatment at 8 weeks
Ocular Surface Disease Index (OSDI) Score. The OSDI is a 12-item questionnaire that assesses dry eye symptoms and their impact on vision-related functioning. Total scores range from a minimum of 0 to a maximum of 100. Higher scores indicate more severe dry eye symptoms and a worse outcome.
3 secondary outcomes
Tear Film Break-Up Time (TBUT)
Time frame: From enrollment to the end of treatment at 8 weeks
Schirmer's Test (without anesthesia)
Time frame: From enrollment to the end of treatment at 8 weeks
Corneal Fluorescein Staining Score
Time frame: From enrollment to the end of treatment at 8 weeks
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 10 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carboxy methyl cellulose and Preservative free Carboxy methyl cellulose in people with Dry Eye Disease (DED), run by Pokhara Academy of Health Sciences, Western Regional Hospital at 1 site in Nepal.
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 4 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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 Nepal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Damodar Sharma, MBBS, MD (+977-9856022583, damodars@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) Score (time frame: From enrollment to the end of treatment at 8 weeks). 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 10 Jun 2026.