NCT02660151

Brief Summary

The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. In addition Hyper-CL™ contact lenses can also provide optical correction during healing if required.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

January 11, 2016

Last Update Submit

May 19, 2019

Conditions

CORNEAL EDEMA

Outcome Measures

Primary Outcomes (2)

  • frequency and severity of all treatment-related adverse events

    Up to 28 days (or 21 days if wash out is not needed).

  • Percent of subjects with corneal thickness decrease of at least 8% and or visual acuity improvement of at least 1 line following treatment with the Hyper-CL™ lens + salt solution

    assess by physiological parameter

    Up to 28 days (or 21 days if wash out is not needed).

Secondary Outcomes (5)

  • Percent of subjects with corneal thickness decrease of at least 8%.

    Up to 28 days (or 21 days if wash out is not needed).

  • Percent of subjects with visual acuity improvement of at least 1 line

    Up to 28 days (or 21 days if wash out is not needed).

  • Corneal thickness decrease

    Up to 28 days (or 21 days if wash out is not needed).

  • change in Measurement Best Corrected Distance Visual Acuity (BCDVA)

    Up to 28 days (or 21 days if wash out is not needed).

  • change in Subject comfort questionnaire

    Up to 28 days (or 21 days if wash out is not needed).

Study Arms (2)

Treatment A-B

EXPERIMENTAL

Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.

Device: Hyper-CL™ lensDevice: Regular soft contact lensDrug: Salt solution

Treatment B-A

EXPERIMENTAL

Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.

Device: Hyper-CL™ lensDevice: Regular soft contact lensDrug: Salt solution

Interventions

Hyper-CL™ lensDEVICE
Treatment A-BTreatment B-A
Regular soft contact lensDEVICE
Treatment A-BTreatment B-A
Salt solutionDRUG
Treatment A-BTreatment B-A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is over 18 years old
  • Subject with corneal edema in the visual access
  • Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema
  • Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

You may not qualify if:

  • Subject with active Herpes keratitis
  • Subject with scarred cornea
  • Subject who is suffering from erosions and/or infections of the cornea (red eye)
  • Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
  • Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
  • Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Soroka MC

Beersheba, Israel

Location

Sheba MC

Ramat Gan, Israel

Location

Katowice MC

Katowice, Poland

Location

Lublin MC

Lublin, Poland

Location

Related Publications (1)

  • Daphna O, Mimouni M, Keshet Y, Ben Ishai M, Barequet IS, Knyazer B, Mrukwa-Kominek E, Zarnowski T, Chen-Zion M, Marcovich A. Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study. J Ophthalmol. 2020 Sep 21;2020:8410920. doi: 10.1155/2020/8410920. eCollection 2020.

    PMID: 33014443DERIVED

MeSH Terms

Conditions

Corneal Edema

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 21, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2018

Study Completion

November 28, 2018

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

IL(2)PL(2)