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Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy (CACICOL-PTK)

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ClinicalTrials.gov Identifier: NCT02373397
Recruitment Status : Terminated (Study terminated due to poor patient recruitment)
First Posted : February 27, 2015
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Region Östergötland
Linkoeping University
Sahlgrenska University Hospital, Sweden
Laboratoires Thea
Information provided by (Responsible Party):
Neil Lagali, Region Östergötland

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.

Condition or disease Intervention/treatment Phase
Corneal Dystrophy, Epithelial Basement Membrane Epithelial Recurrent Erosion Dystrophy Corneal Erosions Device: Cacicol20 Device: Placebo Phase 4

Detailed Description:

Patients undergoing various surgical treatments of the cornea often suffer from a neural deficit, due to nerves being severed or removed completely during surgery. This can result in pain, impaired epithelial wound healing, reduced tear production, symptoms of dry eye, and loss of ocular surface sensitivity/blink reflex. In addition, surgical wound healing can be accompanied by undesirable formation of scar tissue, which can limit postoperative visual acuity. The investigators' prior clinical experience with patients having undergone surgery of the anterior cornea is that neural recovery is slow and incomplete, while in certain situations scar tissue can form and limit the visual recovery.

In this context, CACICOL20®, a regenerative agent approved for use in healing corneal wounds, presents an interesting opportunity for improving postoperative corneal nerve regeneration and a potentially more rapid restoration of the extracellular matrix environment postoperatively, which can lead to improved neural and visual outcomes.

The investigators will therefore evaluate the efficacy of CACICOL20® in a randomized, double-blinded clinical study, to evaluate its ability to promote corneal nerve regeneration, epithelial wound healing, and ocular surface recovery postoperatively.

Upon inclusion and signing of informed consent, patients undergo preoperative examination. Upon satisfying study criteria, patients are randomized to either treatment or placebo group. Group identity is masked to subjects and to investigators (double-blind). Subjects then undergo therapeutic laser treatment of the cornea in a single clinic, followed by instillation of treatment or placebo in the form of 3 eye drops total (to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery).

Postoperative eye examinations are conducted on days 2 and 7 and at month 6 and 12. Examinations include clinical measurement of various eye and corneal wound healing parameters.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy of the Anterior Cornea: A Randomized Double-Blinded Placebo-Controlled Study
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cacicol20
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
Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.
Other Names:
  • RGTA
  • Cacicol
  • RGTA OTR 4120

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




Primary Outcome Measures :
  1. Percentage recovery in subbasal nerve density. [ Time Frame: 12 months postoperative ]
    Degree of corneal subbasal nerve regeneration at one year postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.


Secondary Outcome Measures :
  1. Percentage recovery in subbasal nerve density. [ Time Frame: 6 months postoperative ]
    Degree of corneal subbasal nerve regeneration at 6 months postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.

  2. Percentage of epithelial wound closure. [ Time Frame: 2 and 7 days postoperative. ]
    A drop of sodium fluorescein liquid is applied to the cornea, and a digital photograph is taken at high magnification with a clinical slit lamp biomicroscope, using a blue illumination lamp. Area of open wound is measured from photographs and expressed as a percentage of the total treated area.

  3. Postoperative pain score on the Visual Analog Scale. [ Time Frame: Postoperative day 2, 7, month 6, 12 ]
    Patient self-assessment using the subjective VAS scale (100 point scale).

  4. Corneal haze level. [ Time Frame: Postoperative month 6, 12 ]
    Corneal haze measured microscopically by clinical in vivo confocal microscopy using a semi-quantitative grading scale.

  5. Number of postoperative recurrences of erosions. [ Time Frame: Postoperative month 12. ]
    As reported by the patient.

  6. Ocular surface sensitivity measured by Cochet-Bonnet esthesiometry. [ Time Frame: Postoperative month 6, 12 ]
    Central corneal mechanical touch sensitivity in mm measured by Cochet-Bonnet esthesiometry.

  7. Tear production level [ Time Frame: Postoperative day 7, month 6, 12 ]
    Tear production level (in mm) measured by the Schirmer test without anesthetic.

  8. Tear quality [ Time Frame: Postoperative day 7, month 6, 12 ]
    Tear break up time (in seconds) timed by slit lamp biomicroscopic observation after instillation of sodium fluorescein and induction of blinking.

  9. Improvement in visual acuity [ Time Frame: Postoperative day 7, month 6, 12 ]
    Distance corrected visual acuity improvement measured in Snellen lines gained/lost relative to preoperative level.

  10. Sub basal nerve density measured by clinical in vivo confocal microscopy [ Time Frame: Postoperative 6 and 12 months ]
    Sub basal nerve density level measured by clinical in vivo confocal microscopy.

  11. Epithelial cell density measured by clinical in vivo confocal microscopy [ Time Frame: Postoperative 12 months ]
    Epithelial wing cell density measured by clinical in vivo confocal microscopy.


Other Outcome Measures:
  1. Number of patients with adverse events as a measure of safety and tolerability. [ Time Frame: From operation day until 12 months postoperative. ]
    Defined as reactions or complications beyond those normally expected after laser corneal surgery. Assessed by the investigator.

  2. Number of patients using supplementary eye treatments. [ Time Frame: Operation day until 12 months postoperative. ]
    Use of any supplementary eye treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Specific exclusion criteria for women

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373397


Locations
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Sweden
Linköping University Hospital
Linköping, Sweden, SE-58183
Sahlgrenska University Hospital
Mölndal, Sweden
Sponsors and Collaborators
Neil Lagali
Region Östergötland
Linkoeping University
Sahlgrenska University Hospital, Sweden
Laboratoires Thea
Investigators
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Study Chair: Sven Jarkman, MD PhD Region Östergötland

Publications:

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Responsible Party: Neil Lagali, Associate Professor, Region Östergötland
ClinicalTrials.gov Identifier: NCT02373397     History of Changes
Other Study ID Numbers: 2014/465-31
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by Neil Lagali, Region Östergötland:
Wound healing
nerve regeneration
re-epithelialization
corneal epithelium
laser corneal surgery
Additional relevant MeSH terms:
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Cogan Syndrome
Vestibulocochlear Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions