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Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Dry Eye (DEDCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074344
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pasquale Aragona, Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Brief Summary:

Background: Dry eye disease (DED) is a common condition causing burden on visual function and reducing quality of life. Corticosteroids and/or cyclosporine eye drops are able to improve DED symptoms, however, side effects of immune suppression and cost lead patients often to suspend treatment. Consequently, is important to identify therapies alleviating DED symptoms. A randomized, controlled, single masked study, was performed in 40 patients affected by mild to moderate DED, to evaluate efficacy and safety of a collyrium based on cross-linked hyaluronic acid (XLHA) added with Coenzyme Q10 (CoQ10) in comparison to an eye drop considered a gold standard for tear substitutes, based on hyaluronic acid (HA) 0.15%.

Methods: eye drops were administered four times a day for 90 days to enrolled subjects divided in two groups: group A treated with XLHA+CoQ10, group B treated with HA. Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure (IOP), fundus exam, tear break-up time (TBUT), corneal and conjunctival fluorescein staining, corneal esthesiometry, corneal confocal microscopy, were performed at different visits until the 90th day.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Device: XLHA+CoQ10 Device: Hyaluronic acid (HA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, single-masked, parallel-group comparative study.
Masking: Single (Investigator)
Masking Description: Visits were carried out in a blind fashion by investigators who were not aware to which group the patients belonged. The patients were allowed to know the brand name of the eye drops they were using.
Primary Purpose: Treatment
Official Title: Study on the Effectiveness of Eye-drops Containing Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Patients With Mild to Moderate Dry Eye
Study Start Date : May 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XLHA+CoQ10
XLHA+CoQ10 eye drop administered four times a day for 12 weeks (90 days).
Device: XLHA+CoQ10
XLHA+CoQ10 for four times a day for 12 weeks.
Other Name: VisuXL®

Active Comparator: Hyaluronic acid (HA)
Hyaluronic acid (HA) eye drop administered four times a day for 12 weeks (90 days).
Device: Hyaluronic acid (HA)
Hyaluronic acid (HA) for four times a day for 12 weeks.




Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) questionnaire. [ Time Frame: Up to 90 days. ]
    The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. OSDI demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

  2. Corneal and conjunctival staining. [ Time Frame: Up to 90 days. ]
    Corneal and conjunctival staining of the ocular surface after instillation of vital dyes was developed to quantify epithelial surface damage in dry eye patients. Ocular surface fluorescein stain score was assessed 3 minutes after the instillation of fluorescein; a modified Oxford score was used: cornea and conjunctiva were scored separately from 0 to 5 (from 0 = none to 5 = extended areas of confluent stain), for the conjunctiva a mean for the scores from the nasal and temporal regions was used. The ocular surface was observed through a cobalt blue light and a Wratten #12 yellow filter.The difference among the scores obtained in each visit was calculated.


Secondary Outcome Measures :
  1. Visual acuity, [ Time Frame: Up to 90 days. ]
    Visual acuity refers to the ability to discern fine distinctions in the environment.

  2. Intraocular pressure (IOP). [ Time Frame: Up to 90 days. ]
    IOP = eye fluid pressure measured by tonometry.

  3. Fundus exam. [ Time Frame: Up to 90 days. ]
    Fundus exam is observed after use of mydriatic drops enlarging the pupil.

  4. Tear break-up time (TBUT). [ Time Frame: Up to 90 days. ]
    Tear breakup time (TBUT) is a test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film then and the patient is asked not to blink while the tear film is observed under cobalt blue illumination. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps photos over time. A TBUT under 10 seconds is considered abnormal.

  5. Corneal esthesiometry. [ Time Frame: Up to 90 days. ]
    Esthesiometry measures sensation, specifically tactile.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 18 and 80 years,
  • history of at least 3 months of dry eye symptoms referable to mild to moderate dry eye.

Exclusion Criteria:

  • presence of any ocular disease, present or past, other than dry eye;
  • previous ocular surgery,
  • use of contact lens or topic treatments other than tear substitutes;
  • presence of systemic diseases requiring a treatment with systemic drugs potentially interfering with tear productions;
  • hypersensitivity to the active substance or to excipients;
  • participation in a clinical trial during the 3 months prior to the beginning of the study,
  • pregnancy or breast-feeding.

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): NCT03074344


Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Investigators
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Principal Investigator: Pasquale Aragona, MD Azienda Ospedaliera Universitaria Policlinico "G. Martino", Messina, Italy
Publications of Results:
Other Publications:
Faulkner WJ, Varley GA. Corneal diagnostic techniques. In: Krachmer JH, Mannis MJ, Holland EJ, eds. Cornea. 2nd ed. Vol. 1 Philadelphia: Elsevier/Mosby; 2005:229-235.

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Responsible Party: Pasquale Aragona, Full Professor of Ophtalmology, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
ClinicalTrials.gov Identifier: NCT03074344    
Other Study ID Numbers: AOUGMartino
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pasquale Aragona, Azienda Ospedaliera Universitaria Policlinico "G. Martino":
Dry Eye Syndrome
artificial tear
CoQ10
Hyaluronic acid
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents