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.

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.

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.