Status:
ACTIVE_NOT_RECRUITING
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Lead Sponsor:
Superior University
Conditions:
Evaporative Dry Eye
Eligibility:
All Genders
18-55 years
Phase:
NA
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06913387
Start Date
March 20 2025
End Date
February 20 2026
Last Update
July 15 2025
Active Locations (1)
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1
Mughal eye Hospital Johar town
Lahore, Punjab Province, Pakistan