Evaporative Dry Eye
Conditions
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 (18-55 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.
Interventions
COMBINATION_PRODUCTLipid 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_PRODUCTAqueous 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.
Sponsors
Superior University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 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). |
| SANDE Questionnaire (Symptom Assessment in Dry Eye) | 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 |
| Meibum Test Score | 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. |
| Tear Break-up Time (TBUT): ( without anesthesia) | 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. |
| Schirmer Test I | 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 |
Countries
Pakistan
Outcome results
None listed