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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Latanoprost

About this trial

This is an interventional basic science trial for Open Angle Glaucoma focused on measuring Central corneal thickness, 24hour fluctuation of intraocular pressure, Open angle glaucoma, Ocular hypertension

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ocular hypertensives

Arm Description

This study includes two groups. Subjects with ocular hypertension and 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.

Outcomes

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.

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.

Full Information

NCT ID

NCT00941525

First Posted

July 15, 2009

Last Updated

July 2, 2015

Sponsor

Aristotle University Of Thessaloniki

1. Study Identification

Unique Protocol Identification Number

NCT00941525

Brief Title

Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Acronym

CCT-IOP

Official Title

Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Ocular Hypertension

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ocular hypertensives

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Other Intervention Name(s)

0.005% Xalatan

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

Before and after a 4-weeks period of treatment with latanoprost.

Secondary Outcome Measure Information:

Title

Time Frame

Before and after a 4-weeks period of treatment with latanoprost.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fotis Topouzis, MD

Organizational Affiliation

Aristotle University Of Thessaloniki

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

15350314

Citation

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Results Reference

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PubMed Identifier

10782622

Citation

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Results Reference

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PubMed Identifier

17070596

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

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

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