CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
XLHA+CoQ10 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03074344
NCT03074344N/ACompleted

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

Azienda Ospedaliera Universitaria Policlinico "G. Martino"·interventional·Posted Mar 8, 2017·Updated Mar 10, 2017

In Brief

A clinical study evaluating XLHA+CoQ10 and Hyaluronic acid (HA) for Dry Eye Syndrome. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 8, 2017
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.3 years ago

Interventions

XLHA+CoQ10device

XLHA+CoQ10 for four times a day for 12 weeks.

Hyaluronic acid (HA)device

Hyaluronic acid (HA) for four times a day for 12 weeks.