Evaluation of the effect of saffron extract and vitamin A supplement in the control and treatment of dry eye symptoms

Evaluation of the effect of saffron extract and vitamin A supplement in the control and treatment of dry eye symptoms in patients referred to the Visual Health Center

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210926052587N1

Enrollment

120

Registered

2022-07-16

Start date

2021-11-22

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Dry eye syndrome. Dry eye syndrome of unspecified lacrimal gland

Interventions

Intervention 1: 30 patients are randomly assigned to the control group and receive placebo for 90 days or 3 months. Each placebo capsule contains 35 mg of microcrystalline cellulose, maltodextrin and

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Best corrected visual acuity. Timepoint: Day 0 and Day 90. Method of measurement: Snellen chart.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhosrow Jadidi

The Vision Health Center of Tehran, Iran

kh.jadidi@gmail.com+98 21 8819 6871

Outcome results

None listed

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