Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease

NCT07635849 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CTRL-DEDCMC-PRVFREE/WITHPRV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (3)

• Tear Film Break-Up Time (TBUT)

  From enrollment to the end of treatment at 8 weeks

• Schirmer's Test (without anesthesia)

  From enrollment to the end of treatment at 8 weeks

• Corneal Fluorescein Staining Score

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (1)

• Safety and Tolerability (Adverse Effects)

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Patients with DED receiving CMC with preservative

ACTIVE COMPARATOR

40 patients will receive drops in the eye

Drug: Carboxy methyl cellulose

Patients with DED receiving CMC without preservative

ACTIVE COMPARATOR

40 patients will receive drops in the eye

Drug: Preservative free Carboxy methyl cellulose

Interventions

Preservative free Carboxy methyl cellulose DRUG

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.

Also known as: preservative-free CMC

Patients with DED receiving CMC without preservative

Carboxy methyl cellulose DRUG

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.

Also known as: preserved CMC

Patients with DED receiving CMC with preservative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Clinical diagnosis of Dry Eye Disease (OSDI \>13 and TBUT \<10 seconds)
• Willingness to provide written informed consent

You may not qualify if:

• Contact lens use
• Active ocular infection or inflammation
• History of ocular surgery within the past 6 months
• Use of systemic immunosuppressive therapy

Sponsors & Collaborators

• Pokhara Academy of Health Sciences, Western Regional Hospital: lead

Study Sites (1)

Pokhara Academy of Health Sciences

Pokhara, Gandaki, 33700, Nepal

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Damodar Sharma, MBBS, MD

CONTACT

+977-9856022583; damodars@outlook.com

Jamuna Gurung, MBBS, MD

CONTACT

+977-9860314317; jamunaorama@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Department, Department of Pharmacology,

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)