MedPath

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

Phase 4
Conditions
Health Condition 1: H578- Other specified disorders of eye and adnexa
Registration Number
CTRI/2023/03/050741
Lead Sponsor
Divisa Herbals Pvt. Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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 <= 30 days of enrolment.

7.Persistent contact lens users.

8.Not willing to sign the informed consent form.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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