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

NCT06913387 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/792
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaporative Dry Eye

Outcome Measures

Primary Outcomes (5)

• Ocular Surface Disease Index (OSDI)

  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).

  12 Months

• SANDE Questionnaire (Symptom Assessment in Dry Eye)

  Measures the frequency and severity of dry eye symptoms. Score ranges from 0-100. Scoring: Higher scores indicate more severe and frequent symptoms

  12 Months

• Meibum Test Score

  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.

  12 Months

• Tear Break-up Time (TBUT): ( without anesthesia)

  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.

  12 months

• Schirmer Test I

  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

  12 Months

Study Arms (2)

Lipid Based Artificial Tears

EXPERIMENTAL

Combination Product: Lipid Based Artificial Tears

Aqueous Based Artificial Tears

EXPERIMENTAL

Combination Product: Aqueous Based Artificial Tears

Interventions

Lipid Based Artificial Tears COMBINATION_PRODUCT

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.

Lipid Based Artificial Tears

Aqueous Based Artificial Tears COMBINATION_PRODUCT

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.

Aqueous Based Artificial Tears

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Mughal eye Hospital Johar town

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: March 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: February 20, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)