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
|Condition or disease||Intervention/treatment||Phase|
|Corneal Dystrophy, Epithelial Basement Membrane Epithelial Recurrent Erosion Dystrophy Corneal Erosions||Device: Cacicol20 Device: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
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.
Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.
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.
Vehicle only in identical packaging, with identical dosage and administration route.
- 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.
- 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.
- 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.
- 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).
- 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.
- Number of postoperative recurrences of erosions. [ Time Frame: Postoperative month 12. ]As reported by the patient.
- 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.
- Tear production level [ Time Frame: Postoperative day 7, month 6, 12 ]Tear production level (in mm) measured by the Schirmer test without anesthetic.
- 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.
- 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.
- 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.
- 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.
- 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.
- Number of patients using supplementary eye treatments. [ Time Frame: Operation day until 12 months postoperative. ]Use of any supplementary eye treatments.
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
|Linköping University Hospital|
|Linköping, Sweden, SE-58183|
|Sahlgrenska University Hospital|
|Study Chair:||Sven Jarkman, MD PhD||Region Östergötland|