Investigating the effect of Viola Odorata ophthalmic ointment on dry eye disease: a randomized clinical trial

Determining the effect of Violet flower extract on improving the symptoms of patients with dry eye disease

A 3-blind, placebo-controlled, parallel-group, randomized, phase 3 clinical trial in 52 patients. Randomization is done with random number table and Random Allocation Software.

Patients with dry eye symptoms are examined and diagnosed by an ophthalmologist at Khatam Al Anbia Hospital or private office in Mashhad. Clinical examinations and imaging are performed in order to determine the degree of dry eye using a keratograph. The OSDI and DEQ-5 questionnaires and brain temperament questionnaire are completed by the resident responsible for the project. The patients will be randomly divided into two groups: drug and placebo. 4 weeks later they are checked again by the specialist. In the intervals of 2 and 4 weeks after the intervention, the mentioned forms are completed again for all patients. All objective tests are repeated 4 weeks after intervention using the keratograph.

Inclusion criteria: Patients with complaints of dry eyes; Score of OSDI questionnaire more than 12 and DEQ-5 more than 6; Consent to treatment with herbal medicines; No active eye infection; No history of refractive surgery; Absence of pterygium disease; Not using medicines with dry eye side effect

The intervention group received 15 gram ophthalmic ointment containing water extract of violet flower (2 grams per hundred ml) and artificial tears, and the control group received 15 gram ophthalmic ointment containing placebo and artificial tears.

Foreign body sensation, sensitivity to light, blurred vision, eye irritation Tear breakup time (TBUT), meniscus tear height, conjunctival redness and meibomian gland grade

Due to patient's safety, drug form was changed from eye drop to ophthalmic ointment.

The randomization method in this design will be block method. Blocks of 4 will be used and the sequence produced by the website https://www.sealedenvelope.com will be provided by the project methodologist and will be placed in closed, sealed, opaque and numbered envelopes and the researcher assistant opens one of the envelopes and the patient will be allocated to the group mentioned in the envelope.

The drug and placebo will be packed in the same cans, and only the code and method of administration will be written on them. The patient and specialist and the statistical analyst are unaware of the assigned codes, and at the end of the study, the code is decoded by an informed person. The participant, the researcher, the statistical analyst and Data Safety and Monitoring Committee are unaware of the arrangement of groups.