Eye drops made of antibodies for dry eye disease patients.

Phase 2

Conditions: Health Condition 1: H041- Other disorders of lacrimal gland

Registration Number: CTRI/2021/02/031182

Lead Sponsor: Dr RP Centre of Ophthalmic Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures