Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06288945
Other study ID # Dry eye syndrome
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date September 14, 2023

Study information

Verified date February 2024
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions


Description:

Dry eye syndrome (DES) is a prevalent chronic, inflammation resulting in eye discomfort, irritation, tiredness, and visual abnormalities that can make it difficult to read, use a computer, drive, or engage in other activities (1). It represents a set of tears film disorders caused by decreased tears formation or increased tears evaporation; it causes visual symptoms, ocular surface inflammation, and discomfort. In addition, DES leads to impaired visual function and can negatively affect the outcomes of cataract surgery (2).Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 14, 2023
Est. primary completion date September 14, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Age: 20 to 60 years old. - Alert, and able to communicate. Exclusion Criteria: - patients with recent ocular surgeries in the last 3 months

Study Design


Intervention

Other:
Educational Program
The educational program included information about definition and causes of Dry eye syndrome (DES), symptoms of DES, diagnostic measures of DES, differentiation between DES and eye allergy, complications of DES, the effect of DES on vision, management of DES, health education about proper eyelid hygiene, proper nutrition to improve the quality of tear film, measures, and precautions to prevent DES such as avoiding exposure to smoke and environmental changes, avoiding prolonged periods in air-conditioned environments; limiting contact lens use to shorter periods, avoiding staring at the computer screen or smartphone for long periods, and taking frequent breaks. In addition, health education about the importance of compliance with the treatment of DES, and instructions to maintain normal eye and vision in patients with DES.

Locations

Country Name City State
Egypt Faculty of Nursing, Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Akpek EK, Amescua G, Farid M, Garcia-Ferrer FJ, Lin A, Rhee MK, Varu DM, Musch DC, Dunn SP, Mah FS; American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. Dry Eye Syndrome Preferred Practice Pattern(R). Ophthalmology. 2019 Jan;126(1):P286-P334. doi: 10.1016/j.ophtha.2018.10.023. Epub 2018 Oct 23. No abstract available. — View Citation

Al-Mohtaseb Z, Schachter S, Shen Lee B, Garlich J, Trattler W. The Relationship Between Dry Eye Disease and Digital Screen Use. Clin Ophthalmol. 2021 Sep 10;15:3811-3820. doi: 10.2147/OPTH.S321591. eCollection 2021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision Ocular surface disease index (OSDI) was developed by the Outcomes Research Group at Allergan Inc in 1997 (20). It is a 12-item questionnaire developed to assess ocular irritation symptoms associated with dry eye syndrome and their effect on functions related to vision. 8 months
See also
  Status Clinical Trial Phase
Completed NCT02597803 - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 Phase 2/Phase 3
Completed NCT02522312 - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients N/A
Completed NCT01863368 - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining N/A
Completed NCT01753752 - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation Phase 2
Completed NCT01753687 - Correlation of Different Signs for Assessment of Dry Eye Syndrome N/A
Completed NCT01198782 - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% Phase 4
Completed NCT01212471 - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease Phase 3
Completed NCT01162954 - Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers Phase 1
Completed NCT00544713 - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery N/A
Completed NCT00535054 - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms N/A
Completed NCT00344721 - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome N/A
Completed NCT03830359 - Efficacy, Safety of T2769 in Dry Eye Disease N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Completed NCT02758327 - Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops Phase 4
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Completed NCT01970917 - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects Phase 4
Completed NCT02092207 - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome Phase 2
Completed NCT01541891 - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome Phase 2
Completed NCT01252121 - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline N/A
Completed NCT00765804 - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye Phase 2