Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Dry Eye (DEDCO)
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|ClinicalTrials.gov Identifier: NCT03074344|
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 10, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, single-masked, parallel-group comparative study.|
|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.|
|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|
XLHA+CoQ10 eye drop administered four times a day for 12 weeks (90 days).
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.
- 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.
- 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.
- Visual acuity, [ Time Frame: Up to 90 days. ]Visual acuity refers to the ability to discern fine distinctions in the environment.
- Intraocular pressure (IOP). [ Time Frame: Up to 90 days. ]IOP = eye fluid pressure measured by tonometry.
- Fundus exam. [ Time Frame: Up to 90 days. ]Fundus exam is observed after use of mydriatic drops enlarging the pupil.
- 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.
- Corneal esthesiometry. [ Time Frame: Up to 90 days. ]Esthesiometry measures sensation, specifically tactile.
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
|Principal Investigator:||Pasquale Aragona, MD||Azienda Ospedaliera Universitaria Policlinico "G. Martino", Messina, Italy|