Switching From Preserved to Preserved-free Treatments for Glaucoma.
This study is ongoing, but not recruiting participants.
Sponsor:
Paolo Fogagnolo
Information provided by (Responsible Party):
Paolo Fogagnolo, University of Milan
ClinicalTrials.gov Identifier:
NCT01433900
First received: July 25, 2011
Last updated: September 19, 2011
Last verified: September 2011
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Purpose
A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Tafluprost Drug: Latanoprost |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study. |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by University of Milan:
Primary Outcome Measures:
- Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants [ Time Frame: Month 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity) [ Time Frame: Months 3, 6, 9 ,12 ] [ Designated as safety issue: Yes ]
- Changes in density of epithelial cells, Langerhans cells, endothelial cells [ Time Frame: Month 3, 6, 9 ,12 ] [ Designated as safety issue: Yes ]
- Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test) [ Time Frame: Month 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
|
Drug: Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
|
|
Active Comparator: Latanoprost
1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)
|
Drug: Latanoprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
|
Detailed Description:
The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.
At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
- The patient is newly-diagnosed
- No fluorescein staining at baseline and no observable signs of ocular surface disease
- No treatment with topical BAK-containing products for at least 6 months
- Treatment of naïve patients
Exclusion Criteria:
- Unwilling to sign informed consent
- Not at least 18 years old
- Ocular condition that are of safety concern and that can interfere with the study results
- Closed/barely open anterior chamber angles or history of acute angle closure.
- Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
- Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
- Use of concomitant topical ocular medication that can interfere with study medication
- Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
- Any corneal pathology
- Diabetes at any stage
- Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
- Refractive surgery patients
- Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
- Inability to adhere to treatment/visit plan.
- Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Paolo Fogagnolo, Prof. Luca Rossetti, University of Milan |
| ClinicalTrials.gov Identifier: | NCT01433900 History of Changes |
| Other Study ID Numbers: | MSD-007 |
| Study First Received: | July 25, 2011 |
| Last Updated: | September 19, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Milan:
|
glaucoma intraocular pressure ocular surface benzalkonium chloride |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Latanoprost |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013