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. 2022 Oct 21;2022(10):CD015070. doi: 10.1002/14651858.CD015070.pub2

CTRI/2021/02/031182.

Study name Eye drops made of antibodies for dry eye disease patients: topical human immunoglobulin as adjunct therapy in dry eye disease
Methods

  • Randomized interventional placebo‐controlled trial, parallel group

  • Stratified block randomization

  • Alternation blinding and masking (double masking)
Participants Country: India
Inclusion:

  1. IOP 5 to 22 mmHg in each eye 

  2. TBUT less than 7 seconds 

  3. Schirmer test less than 9 mm per 5 min 

  4. OSDI score of at least 13


Exclusion:

  1. Patients not consenting to participate and follow up, presence of active systemic or ocular infections (including HBV, HCV, and HIV) at the time of initiation of therapy and history of recent ocular surgery in the preceding 6 weeks will not be included in the study 

  2. Allergic to IVIG or any similar products, or excipients of IVIG eyedrops 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


Target sample size: 70
Interventions Intervention: topical immunoglobulin

  1. Topical human IgG eyedrops (4 mg/mL) twice daily for 8 weeks (4 mg/mL)

  2. Topical steroids (prednisolone acetate 1%) + antibiotic (chloramphenicol 1%/polymyxin eyedrops 5000 u/mL eyedrops) 3 times daily for 1 week

  3. Topical carboxymethyl cellulose 4‐hourly 

  4. Topical lubricant ointment at bedtime

  5. Topical immunomodulators: CsA 0.1% eyedrops/tacrolimus 0.03% eye ointment


Control intervention: standard therapy for dry eye disease

  1. Topical steroids (prednisolone acetate 1%) + antibiotic (chloramphenicol 1%/polymyxin eyedrops 5000 u/mL eyedrops) 3 times daily for 1 week

  2. Topical carboxymethyl cellulose 4‐hourly 

  3. Topical lubricant ointment at bedtime

  4. Topical immunomodulators: CsA 0.1% eyedrops/tacrolimus 0.03% eye ointment
Outcomes Time point: outcomes will be measured at baseline and time intervals: 1 and 2 months
Primary outcomes:

  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, Schirmer's I test, Conjunctival Injection Score, tear meniscometry, and tear osmolarity

  5. Tear meniscometry


Secondary outcomes:
Changes in meibomian gland and tear imaging
Starting date 1 March 2021 (date of first enrollment planned)
Contact information Livia Khan; Institution: AIIMS, New Delhi
Prof DrM Vanathi; Institution: AIIMS, New Delhi
Notes Status: not yet recruiting (as of 23 February 2021)