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

N/AActive Not RecruitingNCT06913387

Superior University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Evaporative Dry Eye

Interventions

Lipid Based Artificial TearsCOMBINATION_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 TearsCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mughal eye Hospital Johar town

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 12 Months

Data from ClinicalTrials.gov

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