Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06172530
Other study ID # HL-DQAS-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source Hanlim Pharm. Co., Ltd.
Contact Sol Jo
Phone +82-2-3489-6299
Email ssoljo@hanlim.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is to verify the efficacy and safety in the treatment of dry eye syndrome in patients prescribed with Diquasol eye drops as a monotherapy, or in combination with Hyaluron eye drops, or in combination with Hyaluronmax eye drops.


Description:

This study is to observe the prescription patterns in routine clinical practice and assess the changes in dry eye symptoms, treatment satisfaction, and intraocular tolerance over a 12-week period in patients prescribed with Diquasol eye drops as a monotherapy or in combination with Hyaluron eye drops or Hyaluronmax eye drops for the treatment of dry eye syndrome.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adults aged 19 years and older - Patients with dry eye syndrome with TBUT of 10 or less - Individuals scheduled to receive either Diquasol eye drops as a monotherapy or a combination therapy of Diquasol eye drops with Hyaluron eye drops or Diquasol eye drops with Hyaluronmax eye drops, based on clinical judgment for the treatment of dry eye syndrome - Individuals who have voluntarily provided written consent for participation in this study Exclusion Criteria: - Pregnant or lactating women - Individuals contraindicated according to the approval conditions of Diquasol eye drops, Hyaluron eye drops, and Hyaluronmax eye drops - Cases where the principal investigator or study personnel deem the individual unsuitable for participation in this clinical study

Study Design


Locations

Country Name City State
Korea, Republic of CK St. Mary's Eye Clinic Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Assessment Variables Changes in Tear Break-Up Time (TBUT) after 12 weeks according to each group, including monotherapy with Diquasol eye drops, combination therapy with Diquasol eye drops and Hyaluron eye drops, and combination therapy with Diquasol eye drops and Hyaluronmax eye drops. after 12 weeks of prescription for Diquasol eye drops and Hyaluron/Hyaluronmax eye drops compared to baseline
See also
  Status Clinical Trial Phase
Completed NCT02522312 - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients N/A
Completed NCT02597803 - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 Phase 2/Phase 3
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 NCT01212471 - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease Phase 3
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 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