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Comparison of Autologous Serum Versus Preservative Free Artificial Tear

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ClinicalTrials.gov Identifier: NCT02752763
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Uğur Yılmaz, Niğde State Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 27, 2016
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • Change in Schirmer Test I in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment [ Time Frame: up to 3 Months monthly measurements were done ]
    Schirmer Test I is used for Dry Eye evaluation before and after autologous serum or preservative free artificial tears treatment. Schirmer test is used to measure tear secretion. Schirmer strips are used for this test. Wetting of the paper is recorded in millimeter
  • Change in Break up Time in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment [ Time Frame: up to 3 Months monthly measurements were done ]
    fluorescein sodium eye drops was used for measurement of Break up Time. Value of Break up Time for per eye is recorded as seconds
  • Change in Ocular surface Disease Index in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment [ Time Frame: up to 3 Months monthly measurements were done ]
    OSDI score is a reliable and feasible test which is commonly used for dry eye patients to grade either dry eye symptom severity and its effect on vision-related function. In this index, people are asked to indicate whether they experienced any of the symptoms or problems due to drye eye, if so, how often. Every question asked to patients is scored from one to four according to the frequency of symptoms. The scores were collected from all the questions.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Autologous Serum Versus Preservative Free Artificial Tear
Official Title  ICMJE Comparison of Autologous Serum Versus Preservative Free Artificial Tear in Patients With Dry Eye Due to Systemic Isotretinoin Therapy
Brief 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.
Detailed Description

This prospective, cross-sectional, double blind study was conducted by Ophthalmology Clinic on patients who have drye eye due to systemic isotretinoin treatment for several reasons in Niğde State Hospital between October, 2015 and March 2016. Patients determined as having drye eye during systemic isotretinoin treatment were included to our study. At baseline, 1.and 2. month of study, detailed ocular examination, best corrected visual acuity measurement, intraocular pressure measurement, Tear Break-Up time(TBUT)(5 µL of fluorescein sodium 2 % eye drops was used per each measurement using a pipette for standardization, and the mean value of two readings per patient was recorded) and Schirmer Test I (ST I) without topical anesthesia were performed. Effect on daily life was assessed by using Ocular Surface Disease Index (OSDI) score. TBUT<10 seconds, ST I <10 mm without local anesthesia, corneal and conjunctival staining was interpreted in favor of dry eye. In the follow-up period, investigators investigated the efficacy of autologous serum eye drops for the patients having dry eye illness during isotretinoin treatment. After informed consent, peripheral venous blood (14-20 ml) was drawn from antecubital vein of patients to prepare AS. Blood sample was left at room temperature over 2 hours for clotting. Serum was obtained after centrifugation at 4000 revolutions per minute (rpm) for 10 minutes at 4 °C using a centrifugal device(Nuve NF1200R). Next, in a laminar flow cabinet under sterile conditions, approximately 10 mL of supernatant was collected and diluted to 40 % with isotonic (0.9 % NaCl) saline solution and then 25 mL of preparation was aliquoted into 1.5-mL Eppendorf vials, each of which was wrapped with aluminum foil by the other specialist(Erkut Küçük) for protection against ultraviolet light (to prevent vitamin A degradation), and blinding the patients to the treatment. PFAT eye drops were also placed into different 1.5-ml Eppendorf vials and likewise wrapped with aluminum foil by the other specialist(Erkut Küçük) for blinding the patients. The droppers were also wrapped with aluminum foil for further blinding the patient while applying the eye drops. Patients were randomised via assigned laterality numbers and sealed regime envelopes by the other specialist(Erkut Küçük). Preservative-free isotonic saline was used for washout for 2 weeks prior to beginning of the study.

After the first treatment period (1 month) all patients underwent a 2-week washout period with isotonic saline (0.9 % NaCl) eye drops. Ten a new set of vials (AS or PFAT) was assigned to each patient by the other specialist(Erkut Küçük) for the second treatment period.

After the first 1-month treatment period, patients who had conventional PFAT treatment were switched to AS treatment and the patients who had AS treatment in the first 1-month treatment period were switched to conventional PFAT treat- ment in the second 1-month treatment period, according to the study's crossover nature. The examining ophthalmologist (Uğur Yılmaz) that performed tear function and ocular surface evaluations was blinded to the type of eye drops given to each patient. In addition, the patients were blinded to which treatment they were receiving.

Only the Other specialist (Erkut Küçük), who was not responsible for patient evaluation, knew which patient received which treatment during study periods. All patients were instructed to keep the vials (containing either AS or PFAT) in a refrigerator at 4 °C. All patients were advised to change the vial every other day during the treatment period. TBUT and ST I were administered by the same ophthalmologist (Uğur Yılmaz).

The study was approved Institutional Review Board of Erciyes University, Medicine School. The study was conducted in accordance to Helsinki Declaration. All patients gave written informed consent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: %40 diluted Autologous serum
    Serum that obtained after centrifugation of blood sample
  • Drug: Preservative free artificial tears(Tears naturale free, Refresh single dose eye drop)
    Preservative free artificial tears is a group naming for drops commonly used for drye disease
    Other Names:
    • Tears naturale free(hydroxypropyl methylcellulose)
    • Refresh single dose(polyvinyl Alcohol + Povidone)
Study Arms  ICMJE
  • Experimental: preservative free artificial tear drop
    preservative free artificial tears drop is a drop group declaring different kind of active agent like hydroxypropyl methylcellulose, carboxymethyl cellulose etc commonly used in dry eye treatment. Preservative free artificial tear( carboxymethyl cellulose, hydroxypropyl methylcellulose) was used as four times one drop daily. In our study, we prescribed to patients preservative free artificial tears drop(hydroxypropyl methylcellulose or carboxymethyl cellulose) four times one drop daily.
    Intervention: Drug: Preservative free artificial tears(Tears naturale free, Refresh single dose eye drop)
  • Experimental: %40 Autologous serum(AS)
    peripheral venous blood (14-20 ml) that drawn from antecubital vein of patients to prepare Autologous Serum. Blood sample was left at room temperature over 2 hours for clotting. Serum was obtained after centrifugation at 4000 revolutions per minute (rpm) for 10 minutes at 4 °C using a Nuve NF1200R. Next, in a laminar flow cabinet under sterile conditions, approximately 10 mL of supernatant was collected and diluted to 40 % with isotonic saline solution. It is recommended for dry eye diseases, too. %40 diluted Autologous Serum used as four times one drop daily.
    Intervention: Drug: %40 diluted Autologous serum
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

• isotretinoin use for any reason

Exclusion Criteria:

  • corneal pathologies such as dry eye illness before isotretinoin treatment
  • previous cornea surgery, injury or keratitis
  • active ocular infection
  • meibomian gland dysfunction
  • excessive allergic reaction that may be associated with dry eye
  • glaucoma therapy use
  • severe anemia
  • previously use of PFAT or AS for any reason
  • (Hb<10 g/dL) and elevated hepatic function tests requiring withdrawal of therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02752763
Other Study ID Numbers  ICMJE NSH 333
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Uğur Yılmaz, Niğde State Hospital
Study Sponsor  ICMJE Niğde State Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Uğur Yılmaz, M.D. Niğde State Hospital
PRS Account Niğde State Hospital
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP