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

• Sponsor: Eye-yon Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03845374
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site: 6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Keratitis	Device: Hyper-CL™ lens	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 40 patients will be randomized to one of the following 2 groups: Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens Treatment Group 2: Conventional treatment with topical Antibiotics40 patients will be randomized to one of the following 2 groups: Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens Treatment Group 2: Conventional treatment with topical Antibiotics
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
• Actual Study Start Date: Mar 13, 2019
• Actual Primary Completion Date: Dec 22, 2020
• Actual Study Completion Date: Jan 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional Antibiotics+ Hyper-CL™ lens Conventional treatment with topical Antibiotics+ Hyper-CL™ lens	Device: Hyper-CL™ lens; Use of the Hyper-CL™
No Intervention: Conventional Antibiotics Conventional treatment with topical Antibiotics

Outcome Measures

Primary Outcome Measures

1. Change in Bacterial Keratitis severity score [From date of randomization up to 14 days]

   Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 86 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Medical Center	Haifa		Israel	3109601
2	Sheba Medical Center	Ramat Gan		Israel	52621

Sponsors and Collaborators

• Eye-yon Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eye-yon Medical
• ClinicalTrials.gov Identifier: NCT03845374
• Other Study ID Numbers: CLI-H004
• First Posted: Feb 19, 2019
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Keratitis

Study Results

No Results Posted as of Nov 30, 2021