Eye drops made of antibodies for dry eye disease patients.

Topical human immunoglobulin as adjunct therapy in dry eye disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031182

Enrollment

Registered

2021-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: topical immunoglobulin: 1. Topical human IgG eye drops (4mg/ml) twice daily for eight weeks (4 mg/ml) 2. Topical steroids (prednisolone acetate 1%)+ antibiotic (chloramphenicol 1% / pol

Eligibility

Inclusion criteria

Inclusion criteria: 1. IOP 5 to 22 mmHg in each eye 2. Tear film break up time (TFBUT) less than 7 seconds 3. Schirmers test less than 9 mm per 5min 4. Ocular Surface Disease Index (OSDI) score of at least 13.

Exclusion criteria

Exclusion criteria: 1. Patients not consenting to participate and follow-up, presence of active systemic or ocular infections (including HBV, HCV & HIV) at the time of initiation of therapy and history of recent ocular surgery in the preceding six weeks will not be included in the study. 2. Allergic to IVIG or any similar products, or excipients of IVIG eye drops 4 mg/ml. 3. Use of contact lenses within the last 2-weeks prior to the baseline Visit. 4. Pregnant or nursing/lactating 5. Current diagnosis of any of the following ocular conditions: Acute allergic conjunctivitis, Active infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids) , Active intraocular inflammation (e.g., retinitis, choroiditis, uveitis) 6. A cognitive or psychiatric deficit that precludes informed consent or ability to perform 7. Have active drug/alcohol dependence or abuse

Design outcomes

Primary

Measure	Time frame
The primary outcomes that will be measured will include improvement in the study parameters: 1. Patient Complaint Score 2. UCVA, BCVA 3. OSDI Score 4. Scores of the Ocular Surface Evaluation Tests: (TBUT, NEI Corneal and conjunctival Staining Score Schirmerâ??s I test, Conjunctival Injection Score, tear meniscometry, and tear osmolarity 5. Tear meniscometry Timepoint: Outcomes will be measured at baseline and time intervals: 1 and 2 months	—

Measure

Time frame

The primary outcomes that will be measured will include improvement in the study parameters: 1. Patient Complaint Score 2. UCVA, BCVA 3. OSDI Score 4. Scores of the Ocular Surface Evaluation Tests: (TBUT, NEI Corneal and conjunctival Staining Score Schirmerâ??s I test, Conjunctival Injection Score, tear meniscometry, and tear osmolarity 5. Tear meniscometry Timepoint: Outcomes will be measured at baseline and time intervals: 1 and 2 months

—

Secondary

Measure	Time frame
Changes in Meibomian gland and Tear imagingTimepoint: After 2 months, at interval of 1 month	—

Countries

India

Contacts

Public ContactLivia Khan

AIIMS, New Delhi

mvanathi.rpc@gmail.com9999743762

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026