Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00539526
Other study ID # MA-LUM-07-003
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2007
Est. completion date September 2008

Study information

Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date September 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

- Known contraindication to latanoprost, bimatoprost or travoprost

- Uncontrolled systemic disease

- Active ocular disease other than glaucoma or ocular hypertension

- Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control

Study Design


Intervention

Drug:
Bimatoprost 0.03%
bimatoprost 0.03%, 1 drop nightly for 3 months
travoprost 0.004%
travoprost 0.004% eye drops, 1 drop nightly for 3 months
latanoprost 0.005% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement. Baseline, Month 3
Secondary Change From Baseline in Corneal Staining With Fluorescein at Month 3 Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement. Baseline, Month 3
Secondary Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Baseline, Month 3
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 NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml 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 NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
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 NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4