Clinical Trials Logo
  1. Home
  2. Dry Eye Syndrome
  3. NCT03830359
  4. Details
NCT03830359 Clinical Trial

Efficacy, Safety of T2769 in Dry Eye Disease

Dry Eye Syndrome Clinical Trial

Official title:
Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03830359
Other study ID # LT2769-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date February 18, 2019

Study information
Verified date August 2019
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of T2769 in Dry Eye Desease

Description:

Multicenter and open study

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date February 18, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed and dated informed consent - Male or female aged from = 18 years old - Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening Exclusion Criteria: - Best far corrected visual acuity = 2/10 - Severe blepharitis Severe dry eye

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• T2769
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Locations
Country Name City State
Tunisia Hôpital Universitaire Tahar Sfar Mahdia
Tunisia "Hôpital Universitaire Fattouma Bourguiba Monastir
Tunisia "Hôpital de Forces de Sécurité Intérieure La Marsa Tunis

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Symptomatology Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42. Baseline and Day 42
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 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 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
Completed NCT00514852 - Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye N/A