To evaluate the efficacy and safety of product eye mantra drops in patients suffering from Conjunctivitis, Iritis, Dry Eyes, Eye Strain, Itchy Eyes, And Watery Eyes

A Single Centric, Open-Label, Non-Randomized Phase IV Post- Marketing Surveillance Study To Evaluate The Efficacy And Safety of Eye Mantra Drop in Subjects Suffering From Conjunctivitis, Iritis, Dry Eyes, Eye Strain, Itchy Eyes, And Watery Eyes.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/03/050741

Enrollment

120

Registered

2023-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female subjects aged between 18 to 80 years 2.Subjects with a clinical diagnosis of either conjunctivitis, Iritis, dry eyes, eye strain, itchy eyes, watery eyes, or tired eyes. 3.Be willing to discontinue wearing contact lenses for the duration of the study. 4.Subjects willing to give written informed consent and adhere to all the study procedures.

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant, lactating, or have the potential to bear children. 2.Subjects with uncontrolled diabetes mellitus, ocular trauma, and corneal complications such as marginal corneal ulcer, trachoma, keratoconjunctivitis, etc. 3.Have any clinically significant optic nerve defects. 4.Subjects with a history of recent eye surgery or planning for an eye surgery. 5.Subjects have already taken part in another clinical study (device or drug) within 30 days prior to screening. 6.Active users or have used any topical ocular or systemic antibiotics, topical ocular non-steroidal anti-inflammatory drugs, topical ophthalmic or systemic corticosteroids, non-corticosteroid immunosuppressive agents or other medication such as antispasmodic drugs like atropine within 7.Persistent contact lens users. 8.Not willing to sign the informed consent form.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to evaluate the efficacy of Eye Mantra Drop based on clinical resolution of conjunctivitis, Iritis, dry, itchy, and watery eyes, as well as their anti-inflammatory and anti-allergy potential in healthy subjects.Timepoint: Day 1, Day 7	—

Secondary

Measure	Time frame
1.To assess the efficacy of Eye Mantra Drop in the clinical resolution of fatigued eyes. 2.To evaluate the safety and tolerability of Eye Mantra Drop Timepoint: Day 1, Day 7	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Divisa Herbals Pvt. Ltd.

admin@xplorahealth.com08042115562

Outcome results