CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
%40 diluted Autologous serum +1 moredrug
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/NCT02752763
NCT02752763Phase 4Completed

Comparison of Autologous Serum Versus Preservative Free Artificial Tear in Patients With Dry Eye Due to Systemic Isotretinoin Therapy

Niğde State Hospital·interventional·Posted Apr 27, 2016·Updated Apr 27, 2016

In Brief

A Phase 4 clinical trial evaluating %40 diluted Autologous serum and Preservative free artificial tears(Tears naturale free, Refresh single dose eye drop) for Dry Eye. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic medications. For this reason, many patients using isotretinoin are referred to ophthalmology clinic because of discomfort symptoms. In the literature, there are studies suggesting superiority of Autologous serum drops regarding effects on ocular surface when compared to artificial tear. In addition, Autologous serum was also used in several corneal pathologies with successful outcomes. No data regarding use in the ocular adverse effects of isotretinoin was found in the literature; however, investigators think that it may be an effective alternative in the treatment of dry eye developed during isotretinoin use due to positive effects on ocular surface, epithelial regeneration and anti-inflammatory effect. Autologous serum can be a choice of ophthalmologists in routine practice by increasing number of comprehensive studies investigating effectiveness, safety and long-terms effects of Autologous serum therapy.In this study, it was aimed to investigate dry eye development in the patients receiving systemic retinoic acid therapy and to compare effectiveness of Autologous serum and Preservative free artificial tear in the patients with dry eye disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 27, 2016
Enrollment StartOct 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.2 years ago

Interventions

%40 diluted Autologous serumdrug

Serum that obtained after centrifugation of blood sample

Preservative free artificial tears(Tears naturale free, Refresh single dose eye drop)drug

Preservative free artificial tears is a group naming for drops commonly used for drye disease