RANDOMIZED CLINICAL TRIAL OF ARTIFICIAL TEARS WITH AND WITHOUT PRESERVATIVES IN PATIENTS WITH DRY EYE DISEASE

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Carboxy methyl cellulose; Drug: Preservative free Carboxy methyl cellulose

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Damodar Sharma, MBBS, MD; Phone Number: +977-9856022583; Email: damodars@outlook.com
• Study Contact Backup: Name: Jamuna Gurung, MBBS, MD; Phone Number: +977-9860314317; Email: jamunaorama@gmail.com

Study Locations

• Nepal
  • Gandaki
    • Pokhara, Gandaki, Nepal, 33700
      • Pokhara Academy of Health Sciences
      • Contact: Phanindra Prasad Poudel, Msc, PhD; Phone Number: +977-9846115569; Email: poudelpha@gmail.com
      • Sub-Investigator: Swikriti Shrestha, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with DED receiving CMC with preservative; 40 patients will receive drops in the eye	Drug: Carboxy methyl cellulose; 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.; Other Names: preserved CMC
Active Comparator: Patients with DED receiving CMC without preservative; 40 patients will receive drops in the eye	Drug: Preservative free Carboxy methyl cellulose; 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.; Other Names: preservative-free CMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index (OSDI) Score	This is a validated questionnaire that serves as the primary endpoint to evaluate and compare the improvement in dry eye symptom severity between the two groups.	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Film Break-Up Time (TBUT)	A clinical test used to assess changes in tear film stability	From enrollment to the end of treatment at 8 weeks
Schirmer's Test (without anesthesia)	A test used to evaluate aqueous tear production by measuring wetting length on a filter paper strip	From enrollment to the end of treatment at 8 weeks
Corneal Fluorescein Staining Score	An assessment used to evaluate and grade epithelial damage or defects on the ocular surface	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability (Adverse Effects)	Patient-reported adverse effects will be systematically documented throughout the trial to evaluate the safety and tolerability of the respective artificial tear formulations	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: CTRL-DEDCMC-PRVFREE/WITHPRV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No