A Clinical trial to study the effect of no treatment and polyhexamethylene biguanide in the outcome of keratoconjunctivitis caused by microsporidia.

A prospective, randomized, double masked, placebo controlled trial of topical 0.02% polyhexamethylene biguanide in cases of microsporidial keratoconjunctivitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000792

Enrollment

Registered

2009-12-16

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

None listed

Interventions

Intervention1: Topical administration of 0.02% polyhexamethylene biguanide in the affected eye.: Four hourly eye drop Control Intervention1: Topical administration of Hydroxymethyl cellulose eye drop

Eligibility

Inclusion criteria

Inclusion criteria: a.Patients presenting with superficial epithelial keratitis or keratoconjunctivitis, and their corneal scrapings positive for microsporidia spores. b. Must be able to understand and sign an informed consent form. If the patient is under 18 years of age, the informed consent must be understood and signed by the patient?s parent or guardian.

Exclusion criteria

Exclusion criteria: a.Known allergy to polyhexameththylene biguanide (PHMB). b.Suspected bacterial, viral, or fungal infection based on clinical observation even if the smear is negative.

Design outcomes

Primary

Measure	Time frame
The primary outcome are the time taken for resolution of corneal infiltrate in each group.Timepoint: Day 0, Day 3±1, Day 7±1, Weekly until resolution of corneal lesions.	—

Secondary

Measure	Time frame
The secondary outcome measures are: (a) final visual acuity (b) clinical outcome, and (c) adverse events.Timepoint: At all visits	—

Countries

India

Contacts

Public ContactSujata Das

L V Prasad Eye Institute, Patia, Bhubaneswar

sujatadas@lvpei.org06743987201

Outcome results