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NCT Number: NCT06913387

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Evaporative Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mughal eye Hospital Johar town

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 12 Months

    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).

  2. SANDE Questionnaire (Symptom Assessment in Dry Eye)

    Time frame: 12 Months

    Measures the frequency and severity of dry eye symptoms. Score ranges from 0-100.

    Scoring: Higher scores indicate more severe and frequent symptoms

  3. Meibum Test Score

    Time frame: 12 Months

    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.

  4. Tear Break-up Time (TBUT): ( without anesthesia)

    Time frame: 12 months

    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.

  5. Schirmer Test I

    Time frame: 12 Months

    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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE: A 6 Week RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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