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 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.

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 Timeline

• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Study First Posted: 2025-04-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-12
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-07-20
• 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.

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	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).
SANDE Questionnaire (Symptom Assessment in Dry Eye)	12 Months	Measures the frequency and severity of dry eye symptoms. Score ranges from 0-100.; Scoring: Higher scores indicate more severe and frequent symptoms
Meibum Test Score	12 Months	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.
Tear Break-up Time (TBUT): ( without anesthesia)	12 months	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.
Schirmer Test I	12 Months	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

Trial Locations

Locations (1)

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