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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipid Based Artificial Tears | Experimental |
| |
| Aqueous Based Artificial Tears | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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),
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mughal eye Hospital Johar town | Lahore | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| 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. |
|
| 12 Months |