A Study to Check if Arogya Netram Ayurvedic Eye Drops are Safe and Work Well for Adults with Eye Infection

An Open-Label, Single-Arm, Single-Center Phase 3 Clinical Study to evaluate the Safety and Efficacy of Arogya Netram Ayurvedic Eye Drops in adults with Eye Infection. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098474

Enrollment

Registered

2025-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: H109- Unspecified conjunctivitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female, 18 70 years of age. 2. Presence of ocular redness or mild irritation at baseline, confirmed on clinical examination. 3. Not currently using any other ophthalmic medications. 4. In generally stable health without systemic conditions requiring active therapy that may interfere with study participation. 5. Willing to abstain from contact lens wear throughout the study period. 6. Able and willing to comply with twice-daily instillation, attend scheduled visits, and complete QoL questionnaires and diaries. 7. Signed and dated written informed consent obtained prior to study procedures.

Exclusion criteria

Exclusion criteria: 1. Severe ocular conditions requiring urgent care (e.g., keratitis, corneal ulcer, uveitis, scleritis, endophthalmitis, acute angle-closure). 2. Ocular surgery or trauma within the past 6 months. 3. Known history of severe ocular allergy or hypersensitivity to eye drops/herbal formulations. 4. Pregnant or breastfeeding women. 5. Permanent contact lens dependence or unwillingness to abstain from lens use during the trial. 6. Current participation in another clinical trial or use of an investigational product within 30 days of baseline. 7. Any other condition that, in the investigator s judgment, may compromise safety, compliance, or data integrity.

Design outcomes

Primary

Measure	Time frame
1. Change in conjunctival redness from Baseline (Day 0) to Day 15 and Day 30, as assessed by clinical grading of bulbar conjunctival hyperemia on a standardized scale (e.g., Efron 0 4 scale or equivalent).Timepoint: Visit 1- Screening / Baseline (Day 0) Visit 2- Telephonic Follow-up (Day 7 2) Visit 3- Follow-up (Day 15 2) Visit 4- Telephonic Follow-up (Day 22 2) Visit 5- End of Study (Day 30 2)	—

Secondary

Measure	Time frame
1. Ocular Safety & Tolerability: - Incidence, severity, & type of ocular & systemic adverse events (AEs) throughout the study. - Participants-reported ocular tolerability (stinging, burning, itching, discomfort) captured via diary & AE log. - Investigator global assessment of ocular tolerability at Day 15 & Day 30 (categorical scale: very good, good, fair, poor, very poor). 2. Quality of Life (QoL) Measures: - Change from Baseline to Day 15 & Day 30 in validated QoL questionnaires (e.g., NEI VFQ-25 or equivalent tool chosen for the site). - Domains assessed will include ocular comfort, daily activity impact, emotional well-being, & general physical health.Timepoint: Visit 1- Screening / Baseline (Day 0) Visit 2- Telephonic Follow-up (Day 7 2) Visit 3- Follow-up (Day 15 2) Visit 4- Telephonic Follow-up (Day 22 2) Visit 5- End of Study (Day 30 2)	—

Measure

Time frame

1. Ocular Safety & Tolerability: - Incidence, severity, & type of ocular & systemic adverse events (AEs) throughout the study. - Participants-reported ocular tolerability (stinging, burning, itching, discomfort) captured via diary & AE log. - Investigator global assessment of ocular tolerability at Day 15 & Day 30 (categorical scale: very good, good, fair, poor, very poor). 2. Quality of Life (QoL) Measures: - Change from Baseline to Day 15 & Day 30 in validated QoL questionnaires (e.g., NEI VFQ-25 or equivalent tool chosen for the site). - Domains assessed will include ocular comfort, daily activity impact, emotional well-being, & general physical health.Timepoint: Visit 1- Screening / Baseline (Day 0) Visit 2- Telephonic Follow-up (Day 7 2) Visit 3- Follow-up (Day 15 2) Visit 4- Telephonic Follow-up (Day 22 2) Visit 5- End of Study (Day 30 2)

—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results