Clinical effect of anti-oxidant glasses in dry eye

Clinical effect of anti-oxidant glasses containing extracts of medicinal plants in patients with dry eye disease: a multi-center, prospective, randomized, double-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71217488

Enrollment

Registered

2015-06-23

Start date

2012-09-28

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye is a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort Eye Diseases Other disorders of lacrimal gland

Interventions

Patients were randomly assigned to either the treatment or the placebo group. Participants inthe treatment group received commercially available glasses (EPA II-alpha, BM Biotechnology, Sunchon, South

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). The OSDI was calculated by ([sum of scores for all questions answered]×100)/([total number of questions answered]×5). The OSDI score was evaluated at baseline, 4 weeks, and 8 weeks after treatment.	—

Measure

Time frame

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). The OSDI was calculated by ([sum of scores for all questions answered]×100)/([total number of questions answered]×5). The OSDI score was evaluated at baseline, 4 weeks, and 8 weeks after treatment.

—

Secondary

Measure	Time frame
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) 2. Schirmer’s test (with anesthesia) Both evaluated at baseline, 4 weeks, and 8 weeks after treatment.	—

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026