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Treatment for aqueous deficiency dry eyes

Intraglandular 5-Fluorouracil injection as a potential lacrimation therapy for aqueous deficient dry eyes: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029574
Enrollment
20
Registered
2020-12-04
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: Intra glandular injection of 5- fluorouracil: 2.5mg injected every 4 weeks until there is no further improvement. The injections would continue depending upon the clinical scenario, or

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age more than 12 years 2) Patients diagnosed with cicatrizing conjunctivitis or Stevens-Johnson syndrome or Ocular cicatricial pemphigoid having Schirmer I value between 1-5mm 3) If both eyes match the criteria, then eye with less Schirmer value would be chosen 4) Only those who choose the injection modality and give a valid consent (attached) will be enrolled into the study.

Exclusion criteria

Exclusion criteria: 1) Presence of corneal epithelial defects 2) Schirmer value of zero mm 3) Any ocular surgery within past 3 months 4) Any keratoplasty or ocular surface procedure performed during the trial

Design outcomes

Primary

MeasureTime frame
1. BCVA 2. Ocular surface disease index 3. Schirmer I value (without anesthesia) 4. Corneal and conjunctival hyperemia 5. Corneal epithelial fluorescein staining 6. Slit lamp images- unstained, fluorescein, green filter 7. Tear sampling for future proteomic study Timepoint: 1 and 3 months from the last injection

Secondary

MeasureTime frame
Corneal and conjunctival hyperemia Corneal epithelial fluorescein staining Visual acuityTimepoint: Monthly for one year

Countries

India

Contacts

Public ContactDrSwati Singh

L V Prasad Eye Institute

swatisingh@lvpei.org

Outcome results

None listed

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