Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05825976
Other study ID # IBanjari
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 25, 2023
Est. completion date August 1, 2023

Study information

Verified date April 2023
Source Josip Juraj Strossmayer University of Osijek
Contact Nejra Hodžic, MD
Phone +38735393111
Email nejrahod88@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to determine the effectiveness on the tear film quality and symptoms related with dry eye disease in patients with celiac disease.


Description:

Patients diagnosed with celiac disease will be recruited for the study. They will be randomly assigned to one of the three arms (Intervention group 1 - high dose EPA and DHA, Intervention group 2 - low dose EPA and DHA, or Control - extra virgin olive oil) and for 45 days take supplementation as instructed. During the intervention they will be instructed to maintain their diet and lifestyle (i.e. they will not receive any education on diet or lifestyle modification). At inclusion, patients will complete one basic questionnaire on sociodemographic data, one questionnaire which assess accidental exposure to gluten and their weight and height will be measured. Subjective symptoms related to dry eye disease will be assessed with Ocular Surface Disease Index (OSDI) test, while quality and quantity of the tear film will be assessed with the Schirmer's test I and Tear Break-up Time test (TBUT). Dietary intake of omega-3 acids will be controlled by one 24-hour dietary recall (completed at inclusion an after the intervention).


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - diagnosis of celiac disease - signed informed consent form Exclusion Criteria: - use of medications for diabetes, hypertension, depression, thyroid disease, allergies, epilepsy, psychosis, glaucoma - use of oral contraceptive pills - alcoholism or use of alcohol on the day of recruitment - menopause - eye trauma or surgery in the past 3 months - wearing contact lens - supplementation with omega-3 fatty acids regardless of the dose used in the past month - not understanding Bosnian letter or language - Informed consent form not signed

Study Design


Intervention

Dietary Supplement:
Omega-3 Fatty ACids
Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).
Other:
Control
Supplementation with extra virgin olive oil as a for of positive placebo control.

Locations

Country Name City State
Bosnia and Herzegovina Plava Medical Group Tuzla

Sponsors (2)

Lead Sponsor Collaborator
Josip Juraj Strossmayer University of Osijek Plava Medical Group, Bosna and Herzegovina

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective symptoms of Dry Eye Ocular Surface Disease Index or OSID is a 12-item questionnaire which assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Each question is graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is calculated as OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. Total score ranges from 0 to 100 where higher score coresponds with greater disability. 45 days
Primary Tear Break-up Time Used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The 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. 45 days
Primary Schirmer tear test Evaluates aqueous tear production and is helpful in the assessment of patients with signs and/or symptoms of dry eye. Interpretation: normal aqueous tear production is supported by measurements of > 15 mm after 5 minutes, and mild-moderate reduction of aqueous production: 5mm-14mm after 5 minutes 45 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Recruiting NCT04701086 - 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis N/A
Active, not recruiting NCT03697876 - Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel Phase 1
Terminated NCT02815293 - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Phase 3
Completed NCT02910713 - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation N/A
Completed NCT04104997 - A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers Phase 1
Recruiting NCT02595606 - 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients Phase 4
Completed NCT01711424 - An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease N/A
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT01015209 - Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers Phase 1
Completed NCT00969280 - Acupuncture for Dry Eye Syndrome Phase 3
Completed NCT00739713 - Effects of Sea Buckthorn Oil on Dry Eye N/A
Completed NCT01496482 - Comparison of Evaporimetry With the Established Methods of Tear Film Measurement N/A
Completed NCT00756678 - Efficacy and Acceptability of Two Lubricant Eye Drops Phase 4
Completed NCT00370747 - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome Phase 2
Completed NCT00349440 - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy Phase 4
Completed NCT05162261 - to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction N/A
Completed NCT02871440 - A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye Phase 3
Completed NCT05042960 - Computer Screen Properties Study N/A