Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00788229
Other study ID # dhpat02
Secondary ID
Status Completed
Phase Phase 2
First received November 7, 2008
Last updated April 1, 2010
Start date November 2008
Est. completion date August 2009

Study information

Verified date April 2010
Source Dhp Korea Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female adults aged 18 years and over.

- Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.

- Subjects must agree to discontinue all artificial tears from Screening for 2 weeks

- Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.

- Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening

- Subjects must provide signed informed consent prior to participation in any study-related procedures

- Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.

Exclusion Criteria:

- Pregnancy or lactation.

- Females of childbearing potential who are not using systemic contraception,are not postmenopausal (= 1 year), or are not surgically sterilized.

- Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.

- Any active inflammation of the eye not due to KCS

- Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
AT01
eye drop for 12 weeks
AT02
eye drop for 12 weeks
AT03
eye drop for 12 weeks
AT04
eye drop for 12 weeks

Locations

Country Name City State
Korea, Republic of Asan medical center Seoul 388-1 Pungnap-2dong, Songpa-gu

Sponsors (1)

Lead Sponsor Collaborator
Dhp Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tear Break Up Time (TBUT) 12weeks No
Secondary Fluorescein staining, schirmer test, OSDI, VAS 12 weeks Yes
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
Completed NCT02910713 - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation N/A
Terminated NCT02815293 - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Phase 3
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 NCT00756678 - Efficacy and Acceptability of Two Lubricant Eye Drops Phase 4
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 NCT00349440 - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy Phase 4
Completed NCT00370747 - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome Phase 2
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