NCT02373397

Brief Summary

The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in improving wound healing and nerve regeneration in the anterior cornea, in a patient population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal erosions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

February 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

February 16, 2015

Last Update Submit

March 9, 2020

Conditions

Corneal Dystrophy, Epithelial Basement MembraneEpithelial Recurrent Erosion DystrophyCorneal Erosions

Keywords

Wound healingnerve regenerationre-epithelializationcorneal epitheliumlaser corneal surgery

Outcome Measures

Primary Outcomes (1)

  • Percentage recovery in subbasal nerve density.

    Degree of corneal subbasal nerve regeneration at one year postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.

    12 months postoperative

Secondary Outcomes (11)

  • Percentage recovery in subbasal nerve density.

    6 months postoperative

  • Percentage of epithelial wound closure.

    2 and 7 days postoperative.

  • Postoperative pain score on the Visual Analog Scale.

    Postoperative day 2, 7, month 6, 12

  • Corneal haze level.

    Postoperative month 6, 12

  • Number of postoperative recurrences of erosions.

    Postoperative month 12.

  • +6 more secondary outcomes

Other Outcomes (2)

  • Number of patients with adverse events as a measure of safety and tolerability.

    From operation day until 12 months postoperative.

  • Number of patients using supplementary eye treatments.

    Operation day until 12 months postoperative.

Study Arms (2)

Cacicol20

EXPERIMENTAL

Instillation of Cacicol20 eye drops after laser corneal surgery. 3 eye drops total, to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery.

Device: Cacicol20

Placebo

PLACEBO COMPARATOR

Instillation of placebo eye drops (vehicle missing the active ingredient) after laser corneal surgery. 3 eye drops total, to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery.

Device: Placebo

Interventions

Cacicol20DEVICE

Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.

Also known as: RGTA, Cacicol, RGTA OTR 4120
Cacicol20
PlaceboDEVICE

Vehicle only in identical packaging, with identical dosage and administration route.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Signed and dated informed consent,
  • Male or female aged ≥ 18 years,
  • Patient with recurrent erosions or epithelial dystrophies indicated for treatment by phototherapeutic keratectomy of the anterior cornea

You may not qualify if:

  • In the affected eye: prior corneal surgery
  • In either eye: active ocular infection, glaucoma, or ocular hypertension
  • General history judged by the investigator to be incompatible with the study (life-threatening patient condition).
  • Known allergic hypersensitivity history to Poly(carboxyMethylGlucoseSulfate) or dextran.
  • Inability of patient to understand the study procedures and thus inability to give informed consent.
  • Participation in another clinical study within the last 3 months.
  • Already included once in this study (can only be included for one treated eye)
  • Known pregnancy (if uncertain pregnancy test will be performed)
  • Lactation
  • Women of childbearing potential without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring) or women not hysterectomised, post-menopausal or surgically sterilized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linköping University Hospital

Linköping, SE-58183, Sweden

Location

Sahlgrenska University Hospital

Mölndal, Sweden

Location

Related Publications (7)

  • Meddahi A, Alexakis C, Papy D, Caruelle JP, Barritault D. Heparin-like polymer improved healing of gastric and colic ulceration. J Biomed Mater Res. 2002 Jun 5;60(3):497-501. doi: 10.1002/jbm.1293.

    PMID: 11920675BACKGROUND

  • Chebbi CK, Kichenin K, Amar N, Nourry H, Warnet JM, Barritault D, Baudouin C. [Pilot study of a new matrix therapy agent (RGTA OTR4120) in treatment-resistant corneal ulcers and corneal dystrophy]. J Fr Ophtalmol. 2008 May;31(5):465-71. doi: 10.1016/s0181-5512(08)72462-8. French.

    PMID: 18641578BACKGROUND

  • Lagali N, Germundsson J, Fagerholm P. The role of Bowman's layer in corneal regeneration after phototherapeutic keratectomy: a prospective study using in vivo confocal microscopy. Invest Ophthalmol Vis Sci. 2009 Sep;50(9):4192-8. doi: 10.1167/iovs.09-3781. Epub 2009 Apr 30.

    PMID: 19407024BACKGROUND

  • Germundsson J, Lagali N. Pathologically reduced subbasal nerve density in epithelial basement membrane dystrophy is unaltered by phototherapeutic keratectomy treatment. Invest Ophthalmol Vis Sci. 2014 Mar 25;55(3):1835-41. doi: 10.1167/iovs.13-12533.

    PMID: 24569577BACKGROUND

  • Cejkova J, Olmiere C, Cejka C, Trosan P, Holan V. The healing of alkali-injured cornea is stimulated by a novel matrix regenerating agent (RGTA, CACICOL20): a biopolymer mimicking heparan sulfates reducing proteolytic, oxidative and nitrosative damage. Histol Histopathol. 2014 Apr;29(4):457-78. doi: 10.14670/HH-29.10.457. Epub 2013 Oct 9.

    PMID: 24105332BACKGROUND

  • De Monchy I, Labbe A, Pogorzalek N, Gendron G, M'Garrech M, Kaswin G, Labetoulle M. [Management of herpes zoster neurotrophic ulcer using a new matrix therapy agent (RGTA): A case report]. J Fr Ophtalmol. 2012 Mar;35(3):187.e1-6. doi: 10.1016/j.jfo.2011.09.002. Epub 2011 Oct 19. French.

    PMID: 22015067BACKGROUND

  • Kymionis GD, Liakopoulos DA, Grentzelos MA, Diakonis VF, Klados NE, Tsoulnaras KI, Tsilimbaris MK, Pallikaris IG. Combined topical application of a regenerative agent with a bandage contact lens for the treatment of persistent epithelial defects. Cornea. 2014 Aug;33(8):868-72. doi: 10.1097/ICO.0000000000000169.

    PMID: 24937169BACKGROUND

MeSH Terms

Conditions

Corneal dystrophy, epithelial basement membraneEpithelial Recurrent Erosion Dystrophy

Study Officials

  • Sven Jarkman, MD PhD

    Region Östergötland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 27, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

SE(2)