Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

NCT00941525 | Completed Phase 4

• 2 other identifiers: 83155EudraCT: 2008-004629-41
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Central corneal thickness; 24hour fluctuation of intraocular pressure; Open angle glaucoma; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Ocular hypertensives

OTHER

This study includes two groups. 1. Subjects with ocular hypertension and 2. Controls. Group 2 undergoes only 1 visit (visit 1) without any intervention. Group 1 undergoes visit 1 without intervention. Then they receive treatment (1 eyedrop of latanoprost (0.005%) dosed once a day in both eyes at 8:00pm for a 4-weeks period for 1 month) and undergo the visit 2 under the effect of treatment.

Drug: Latanoprost

Interventions

Latanoprost DRUG

1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period

Also known as: 0.005% Xalatan

Ocular hypertensives

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (14)

• 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. doi: 10.1016/j.ophtha.2004.02.017.

  PMID: 15350314 BACKGROUND

• 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. doi: 10.1097/00061198-200004000-00002.

  PMID: 10782622 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2006.05.075. Epub 2006 Oct 27.

  PMID: 17070596 BACKGROUND

• 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. doi: 10.1001/archopht.120.6.714.

  PMID: 12049575 BACKGROUND

• 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.

  PMID: 10937568 BACKGROUND

• 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. doi: 10.1016/s0039-6257(02)00296-5.

  PMID: 12204704 BACKGROUND

• 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. doi: 10.1001/archopht.121.4.453.

  PMID: 12695241 BACKGROUND

• 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. doi: 10.1016/j.ajo.2004.04.022.

  PMID: 15364220 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2005.10.045.

  PMID: 16458092 BACKGROUND

• 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. doi: 10.1016/j.jcrs.2004.10.044.

  PMID: 15721708 BACKGROUND

• 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. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.

  PMID: 16527231 BACKGROUND

• 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. doi: 10.1167/iovs.06-0557.

  PMID: 17122122 BACKGROUND

• 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. doi: 10.1016/s0161-6420(01)00605-4.

  PMID: 11470697 BACKGROUND

• 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. doi: 10.1167/iovs.06-0507.

  PMID: 17003435 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Fotis Topouzis, MD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

GR (1)