Evaluation of the effect of saffron extract and vitamin A supplement in the control and treatment of dry eye symptoms
Phase 2
Recruiting
- Conditions
- Dry eye syndrome.Dry eye syndrome of unspecified lacrimal glandH04. 129
- Registration Number
- IRCT20210926052587N1
- Lead Sponsor
- Semnan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Inclusion criteria are patients with dry eye. Thus, if a person has a Schmermer test (or SMTUBE) (with anesthesia) less than 10 mm and a tear film rupture test (TBUT) less than 10 seconds, it is a diagnosis of dry eye and will be included in the study.
Exclusion Criteria
Previous history of eye surgery
Previous history of eye disorders
Systemic disorders
Using a contact lense (including soft or hard type)
Failure to fill out the informed consent form
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dry eye (in the present study, dry eye based on the results of the Surface Eye Disease Index (OSDI=13) and TBUT non-invasive (less than 10 seconds), Shermer 1 test (with anesthesia) less than 10 mm and color Eye surface plasticity (OSS) will be defined (color>> 5 corneal points and> 9 conjunctival or eyelid edge points). Timepoint: Measurement of dry eye at the beginning of the study (before the intervention) and 90 days after the start of medication. Method of measurement: (in the present study, dry eye based on the results of the Surface Eye Disease Index (OSDI=13) and TBUT non-invasive (less than 10 seconds), Shermer 1 test (with anesthesia) less than 10 mm and color Eye surface plasticity (OSS) will be defined (color>> 5 corneal points and> 9 conjunctival or eyelid edge points).
- Secondary Outcome Measures
Name Time Method Best corrected visual acuity. Timepoint: Day 0 and Day 90. Method of measurement: Snellen chart.