Clinical effect of anti-oxidant pads in patients with dry eye

Not Applicable

Completed

• Conditions: Dry eye; Eye Diseases; Dry eye syndrome

• Registration Number: ISRCTN10704205
• Lead Sponsor: Korea Forest Service

Brief Summary

2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5758851/ (added 17/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-14
• Study Completion: 2016-12-14
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. One or more dry eye-related ocular symptoms (> 3 months) such as dryness, irritation and burning sensations
2. Ocular Surface Disease Index score from 13 to 32 (mild to moderate)
3. Tear film break-up time (BUT) of <10 s or a Schirmer’s test (with application of a local anaesthetic) value <10 mm for 5 minutes

Exclusion Criteria

1. Pregnant women
2. Active eye and periocular skin inflammation
3. Vitamin A deficiency
4. Previous ocular surgery within 3 months
5. History of diabetic retinopathy, age-related macular degeneration, glaucoma
6. History of wearing contact lenses
7. History of active treatment for dry eyes such as punctal occlusion or the usage of anti-inflammatory eye drops (topical steroid or topical cyclosporin) within 1 month
8. Systemic condition or medication that could cause dry eye

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Change in subjective symptoms of dry eye disease. The subjective symptoms were graded using ocular surface disease index (OSDI) score (0 to 100), with higher scores representing greater disability. The patients answered the 12 items on the OSDI questionnaire that were graded on a scale of 0 to 4 (0: none of the time, 1: some of the time, 2: half of the time, 3: most of the time, 4: all of the time).<br><br> The OSDI was calculated by ([sum of scores for all questions answered]×100)/([total number of questions answered]×5).<br><br> The OSDI score was evaluated at baseline, 4 weeks, and 8 weeks after treatment.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Tear film break up time - the time before the defect of fluorescein dye appeared in the stained tear film was measured and recorded (measured TBUT 3 times and averaged)<br> 2. Schirmer’s test (with anesthesia)<br><br> Both evaluated at baseline, 4 weeks, and 8 weeks after treatment.<br>