Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis

Bacterial Keratitis Clinical Trial

Official title:

Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845374
• Other study ID #: CLI-H004
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: November 2021
• Source: Eye-yon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.

The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.

Description:

The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 11, 2021
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

Inclusion Criteria:

1. Subject is 18-86 years old

2. Subject with Bacterial keratitis in one eye only

3. Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)

4. Best-corrected visual acuity of 6/60 or better in the uninvolved eye

5. No prior antibiotic treatment for current Bacterial Keratitis

6. 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:

1. Perforation or imminent perforation of cornea

2. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb

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. No light perception in the affected eye

9. Pregnancy

10. Other active ocular infection

11. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal

12. Any corneal transplant

13. Post refractive surgery

14. Corneal inlays

15. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.

16. Participation in another clinical study within the past 30 days

Related Conditions & MeSH terms

• Bacterial Keratitis
• Keratitis

Intervention

Device:
• Hyper-CL™ lens
Use of the Hyper-CL™

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Eye-yon Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bacterial Keratitis severity score	Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.	From date of randomization up to 14 days