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Hyper-CLâ?¢ lens to reduce treatment burden in Subjects with Bacterial Keratitis.

Prospective, Randomized Single-Center Post Marketing Study of using Hyper-CLâ?¢ lens to reduce treatment burden in Subjects with Bacterial Keratitis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045043
Enrollment
45
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: H168- Other keratitis

Interventions

Intervention1: Hyper-CLâ?¢ lens with Reducing loading dose of topical Antibiotics(Reduced treatment burden): Treatment Group 1 (Reduced treatment burden): Reducing loading dose in the first hour, foll

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject is 18-86 years old 2.Subject with Bacterial keratitis in one eye only 3.Subject with Bacterial Keratitis infiltrate of at least 1.5 mm in diameter 4.Subjects with no prior antibiotic treatment or treatment up to 12 hours prior enrolment. 5.Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion criteria

Exclusion criteria: 1.Perforation 2.Subject with elevated bleb (glaucoma shunts) 3.Sign of inflammation in both eyes 4.Severe itching suggesting viral infection or allergy reaction 5.Subepithelial infiltrate suggesting viral infection 6.Dendrite like ulcer or suspecting of Herpes keratitis 7.Previous penetrating keratoplasty 8.Pregnancy 9.Any infiltration suggesting other than bacterial infection e.g., parasite, fungal. 10.Post refractive surgery 11.Corneal inlays 12.Subject with neuropathic corneas 13.Subjects with Chronic autoimmune diseases 14.Any other condition which in the opinion of the investigator would place the patient at undue risk for participation. 15.Participation in another clinical study within the past 30 days 16.Patient requires different treatment regimen then determined by the study protocol.

Design outcomes

Primary

MeasureTime frame
Change in average diameter of epithelial defect over timeTimepoint: up to 14 days

Secondary

MeasureTime frame
Change from baseline in Pain score over timeTimepoint: up to 14 days;Change in Bacterial Keratitis severity at day 3Timepoint: up to 14 days;Change in cell in AC over timeTimepoint: up to 14 days;Change in Visual Acuity over timeTimepoint: up to 14 days;Time for significant improvement in Bacterial Keratitis severity - 50% reduction in epithelial defect.Timepoint: up to 14 days

Countries

India

Contacts

Public ContactProf A Heber

Dr. Agarwals Eye Hospital

drlionalraj@dragarwal.com8754411261

Outcome results

None listed

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