NCT06913387

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Evaporative Dry Eye

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lipid Based Artificial Tears	30 participants received lipid-based artificial tears (Recuro) in this study arm. The intervention involved the administration of RECURO EYE DROPS, which contain Sodium carboxymethylcellulose 0.5%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period.
COMBINATION_PRODUCT	Aqueous Based Artificial Tears	30 participants received aqueous-based artificial tears (Softeal) in this study arm. The intervention involved the administration of SOFTEAL EYE DROPS, which contain Hydroxypropylmethyl Cellulose 0.3%. Participants were instructed to instill 1-2 drops in each eye, three times daily (morning, afternoon, and evening) throughout the 6-week trial period.

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-07-20
• Completion: 2026-02-20
• First posted: 2025-04-06
• Last updated: 2025-07-15

Locations

1 site across 1 country: Pakistan