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

Superior University

Status

Active, not recruiting

Conditions

Evaporative Dry Eye

Treatments

Combination Product: Lipid Based Artificial Tears

Combination Product: Aqueous Based Artificial Tears

Study type

Interventional

Funder types

Other

Identifiers

NCT06913387

MSRSW/Batch-Fall23/792

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.