Trials / Completed
CompletedNCT03845374
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Eye-yon Medical · Industry
- Sex
- All
- Age
- 18 Years – 86 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hyper-CL™ lens | Use of the Hyper-CL™ |
Timeline
- Start date
- 2019-03-13
- Primary completion
- 2020-12-22
- Completion
- 2021-01-11
- First posted
- 2019-02-19
- Last updated
- 2021-11-30
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT03845374. Inclusion in this directory is not an endorsement.