Clinical Trials Logo
  1. Home
  2. Ocular Hypertension
  3. NCT01037036
  4. Details
NCT01037036 Clinical Trial

A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

Ocular Hypertension Clinical Trial

Official title:
An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01037036
Other study ID # PPL GLAU 08
Secondary ID
Status Completed
Phase Phase 2
First received December 17, 2009
Last updated December 10, 2013
Start date December 2009
Est. completion date July 2010

Study information
Verified date December 2013
Source Mati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Over 18 years

- Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

- Currently on prostaglandin therapy

Exclusion Criteria:

- Uncontrolled medical conditions

- Subjects who wear contact lenses

- Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost Punctal Plug Delivery System
To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
• Xalatan
Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Locations
Country Name City State
United States Menlo Park Menlo Park California

Sponsors (2)
Lead Sponsor Collaborator
Mati Therapeutics Inc. QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in IOP measurements 4 weeks No
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2