Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Evaporative Dry Eye
• Intervention / Treatment: Combination product: Lipid Based Artificial Tears; Combination product: Aqueous Based Artificial Tears

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Mughal eye Hospital Johar town

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipid Based Artificial Tears	Combination product: Lipid Based Artificial Tears; 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.
Experimental: Aqueous Based Artificial Tears	Combination product: Aqueous Based Artificial Tears; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	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.	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	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): July 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Ophthalmic Solutions; Pharmaceutical Solutions; Lubricant Eye Drops
• Other Study ID Numbers: MSRSW/Batch-Fall23/792

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