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

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost

Study type: Interventional

Funder types: Other

Identifiers

NCT00941525

EudraCT: 2008-004629-41

83155

Details and patient eligibility

About

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).

Enrollment: 174 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

174 participants in 1 patient group

Ocular hypertensives

Other group

Description:

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.

Treatment:

Drug: Latanoprost