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Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure (CCT-IOP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941525
First Posted: July 17, 2009
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fotis Topouzis, Aristotle University Of Thessaloniki
  Purpose

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).


Condition Intervention Phase
Open Angle Glaucoma Ocular Hypertension Drug: Latanoprost Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Fotis Topouzis, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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. [ Time Frame: Before and after a 4-weeks period of treatment with latanoprost. ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Before and after a 4-weeks period of treatment with latanoprost. ]

Enrollment: 174
Study Start Date: September 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ocular hypertensives

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941525


Locations
Greece
A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Fotis Topouzis, MD Aristotle University Of Thessaloniki
  More Information

Publications:

Responsible Party: Fotis Topouzis, Professior, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00941525     History of Changes
Other Study ID Numbers: 83155
EudraCT: 2008-004629-41
First Submitted: July 15, 2009
First Posted: July 17, 2009
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Fotis Topouzis, Aristotle University Of Thessaloniki:
Central corneal thickness
24hour fluctuation of intraocular pressure
Open angle glaucoma
Ocular hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents