Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Study Overview
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Brief Summary
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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).

Official Title
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Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Latanoprost


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ocular hypertensives<br>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. | Drug: Latanoprost<br>* 1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period<br>* Other names: 0.005% Xalatan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central corneal thickness, 24hour fluctuation of intraocular pressure, Open angle glaucoma, Ocular hypertension