Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome

University of Alicante

Status: Begins enrollment in 2 months

Conditions: Dry Eye Syndrome

Treatments: Dietary Supplement: Saffron extract (Crocus sativus); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06240364

PHARMACTIVE1-24I

Details and patient eligibility

About

Previous research has demonstrated the effectiveness of AFFRONEYE® / CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to compare the results of clinical tests that evaluate signs and symptoms for the diagnosis of dry eye, between two groups (some that take the dietary supplement and others a placebo), in a sample of university workers and students who suffer from dry eye.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have dry eye according to the diagnostic criteria established by the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS).

Exclusion criteria

• Pathology of the anterior ocular surface under treatment (such as conjunctivitis, keratitis, among others).
• Take any type of dietary supplements, with or without botanical components in the last month.
• Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups, including a placebo group

Saffron extract (Crocus sativus)

Experimental group

Description:

Daily intake of one tablet for 84 days.

Treatment:

Dietary Supplement: Saffron extract (Crocus sativus)

Placebo

Placebo Comparator group

Description:

Daily intake of one tablet for 84 days. This tablet is organoleptically indistinguishable from the experimental tablet.

Treatment:

Dietary Supplement: Placebo