Ocular Hypertension Clinical Trial
— CCT-IOPOfficial title:
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
The purpose of this study is to determine whether 24-hour fluctuation of intraocular
pressure (IOP) is associated with central corneal thickness (CCT) in subjects with ocular
hypertension or open angle glaucoma and in age-matched controls. Also to evaluate whether
mean IOP reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT,
after a 4-weeks period of treatment.
Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis
(CH) measured by Ocular Response Analyzer (ORA).
Status | Completed |
Enrollment | 174 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: Males and females >50 years old with: - Primary Open-Angle Glaucoma newly diagnosed or with anti-glaucoma medical treatment < =12 weeks - Pseudoexfoliative Glaucoma newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks - Ocular Hypertensives newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks - Age-matched controls - IOP>=22mmHg at the eligibility visit for glaucoma patients and ocular hypertensives Exclusion Criteria: For Eye - Use of any ophthalmic medication (drops) during the study (except for natural tears) - Inflammation of any aetiology - Previous eye surgery or laser - Corneal abnormalities (oedema, dystrophies etc) For Subjects - Systemic diseases which affect the cornea (such as autoimmune diseases) - Inability to participate due to advanced age or serious illness - Mean IOP>36mmHg in either eye at the eligibility visit. - Subjects who cannot safety discontinue use of all IOP-lowering medication(s) for washout - Subjects with severe central visual field loss in either eye. Severe central visual field loss is defined as sensitivity <=10dB in at least 2 of the 4 visual field test points closest to the point of fixation - Other types of glaucoma (such as angle-closure glaucoma and secondary glaucomas) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Greece | A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Asrani S, Zeimer R, Wilensky J, Gieser D, Vitale S, Lindenmuth K. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000 Apr;9(2):134-42. — View Citation
Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. Epub 2006 Mar 9. — View Citation
European Glaucoma Prevention Study (EGPS) Group, Miglior S, Pfeiffer N, Torri V, Zeyen T, Cunha-Vaz J, Adamsons I. Predictive factors for open-angle glaucoma among patients with ocular hypertension in the European Glaucoma Prevention Study. Ophthalmology. 2007 Jan;114(1):3-9. Epub 2006 Oct 27. — View Citation
Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. — View Citation
Kida T, Liu JH, Weinreb RN. Effect of 24-hour corneal biomechanical changes on intraocular pressure measurement. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4422-6. — View Citation
Kotecha A, Elsheikh A, Roberts CR, Zhu H, Garway-Heath DF. Corneal thickness- and age-related biomechanical properties of the cornea measured with the ocular response analyzer. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5337-47. — View Citation
Larsson LI, Mishima HK, Takamatsu M, Orzalesi N, Rossetti L. The effect of latanoprost on circadian intraocular pressure. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S90-6. Review. — View Citation
Larsson LI. Intraocular pressure over 24 hours after repeated administration of latanoprost 0.005% or timolol gel-forming solution 0.5% in patients with ocular hypertension. Ophthalmology. 2001 Aug;108(8):1439-44. — View Citation
Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. — View Citation
Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. — View Citation
Nouri-Mahdavi K, Hoffman D, Coleman AL, Liu G, Li G, Gaasterland D, Caprioli J; Advanced Glaucoma Intervention Study. Predictive factors for glaucomatous visual field progression in the Advanced Glaucoma Intervention Study. Ophthalmology. 2004 Sep;111(9):1627-35. — View Citation
Orzalesi N, Rossetti L, Bottoli A, Fogagnolo P. Comparison of the effects of latanoprost, travoprost, and bimatoprost on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Ophthalmology. 2006 Feb;113(2):239-46. — View Citation
Orzalesi N, Rossetti L, Bottoli A, Fumagalli E, Fogagnolo P. The effect of latanoprost, brimonidine, and a fixed combination of timolol and dorzolamide on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Arch Ophthalmol. 2003 Apr;121(4):453-7. — View Citation
Orzalesi N, Rossetti L, Invernizzi T, Bottoli A, Autelitano A. Effect of timolol, latanoprost, and dorzolamide on circadian IOP in glaucoma or ocular hypertension. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2566-73. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation analyses between mean central corneal thickness (CCT) and 24-hour intraocular pressure (IOP) fluctuation and between mean CCT and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost. | Before and after a 4-weeks period of treatment with latanoprost. | No | |
Secondary | Correlation analyses between corneal hysteresis (CH) and 24-hour intraocular pressure (IOP) fluctuation and between CH and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost. | Before and after a 4-weeks period of treatment with latanoprost. | No |
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 | |
Completed |
NCT02558374 -
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
|
Phase 3 | |
Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
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 |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
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 |
NCT01995136 -
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
|
Phase 4 | |
Completed |
NCT02003547 -
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01693315 -
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 2 | |
Completed |
NCT01664039 -
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
|
Phase 4 | |
Active, not recruiting |
NCT01430923 -
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
|
N/A | |
Completed |
NCT01340014 -
Patient Preference Comparison of AZARGA Versus COSOPT
|
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 |