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

Not Applicable

Active, not recruiting

• Conditions: Evaporative Dry Eye

• Registration Number: NCT06913387
• Lead Sponsor: Superior University

Brief Summary

This randomized clinical trial aims to compare the efficacy of lipid-based (Recuro) versus aqueous-based (Softeal) artificial tears in managing Evaporative Dry Eye (EDE) over six weeks. Conducted in a hospital or ophthalmology clinic, the study includes 60 participants (aged 18-55, both genders) diagnosed with EDE.

Detailed Description

Participants are randomly assigned to receive either lipid-based or aqueous-based artificial tears, following a block randomization method (block size of 4) generated using Research Randomizer. The primary objectives are to assess symptom reduction and improvement in quality of life, measured by the Ocular Surface Disease Index (OSDI) and the SANDE questionnaire. Objective assessments include tear film stability, Meibomian gland function, tear volume, and ocular surface health.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.(16)

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	12 Months	Measures dry eye symptoms and their impact on daily activities.; Scoring: ≥13: Mild to severe dry eye (inclusion criteria met); 0-12: Normal; 13-22: Mild Dry Eye; 23-32: Moderate Dry Eye; 33-100: Severe Dry Eye; 4. Schirmer's Test: Measures tear production using filter paper strips.; Scoring: ≥10 mm in 5 min: Normal; 5-9 mm in 5 min: Mild Dry Eye; \<5 mm in 5 min: Severe Dry Eye
SANDE Questionnaire (Symptom Assessment in Dry Eye)	12 Months	Evaluates frequency and severity of symptoms.; Scoring: Scale of 0 (no symptoms) to 100 (severe symptoms); Final score = (Frequency × Severity) ÷ 100
Tear Break-Up Time (TBUT) Test	12 Months	Assesses tear film stability by measuring how quickly the tear film breaks up after blinking.\<10 seconds: Tear film instability (inclusion criteria met); \>10 seconds: Normal; 5-10 seconds: Borderline stability; \<5 seconds: Severe instability
Meibomian Gland Function Score	12 months	Assesses Meibomian gland health and lipid secretion.; Scoring (0-3 per gland, total 0-45): 0: Clear meibum, no blockage (Healthy); 1. Cloudy meibum, mild dysfunction; 2. Thickened meibum, partial blockage; 3. No secretion, complete blockage (Severe dysfunction)

Trial Locations

Locations (1)

Mughal eye Hospital Johar town; 🇵🇰 Lahore, Punjab, Pakistan