A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertensio
- Conditions
- Glaucomaelevated Intraocular Pressure (IOP)MedDRA version: 14.1Level: PTClassification code 10018304Term: GlaucomaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-004587-29-AT
- Lead Sponsor
- Alcon Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
?Inclusion Criteria:
1. Patients 18 years of age or older
2. Diagnosis of open-angle glaucoma (including open-angle
glaucoma with pseudoexfoliation or pigment dispersion)
or ocular hypertension.
3. Qualifying mean IOP (after washout) at both the
Eligibility 1 and 2 Visits in at least 1 eye (the same eye)
must be:
• = 24 mmHg at the 8 AM (± 30 minutes) time point
and,
• = 21 mmHg at the 10 AM (± 30 minutes) and 4 PM
(± 30 minutes) time points.
Mean IOP must be = 36 mmHg at all time points, OU.
Note: Mean IOP is the average of 2 successive IOP
measurements in the same eye, as described in the Manual
of Procedures. A third measurement is required if the first
2 measurements differ by more than 4 mmHg.
4. Must be able to understand and sign an informed consent
form that has been approved by an Institutional Review
Board/Independent Ethics Committee.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360
?1. Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are ?excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy
throughout the study.
?Related to disease/condition being investigated (either eye)
2. Modified Shaffer angle grade < 2 as measured by
gonioscopy (extreme narrow angle with complete or
partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
vertical measurement).
4. Severe central visual field loss defined as a sensitivity
= 10 dB in at least 2 of the 4 visual field test points closest
to the point of fixation.
5. Patients who in the opinion of the Investigator cannot
discontinue all IOP-lowering ocular medication(s) per the
appropriate washout schedule prior to the E1 Visit.
Excluded from participation if they are currently pregnant,
have a positive result on the urine pregnancy test at
Screening, or intend to become pregnant during the study
period; are breast-feeding; or are not in agreement to use
adequate birth control methods to prevent pregnancy
throughout the study.
Related to disease/condition being investigated (either eye)
2. Modified Shaffer angle grade < 2 as measured by
gonioscopy (extreme narrow angle with complete or
partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
vertical measurement).
4. Severe central visual field loss defined as a sensitivity
= 10 dB in at least 2 of the 4 visual field test points closest
to the point of fixation.
5. Patients who in the opinion of the Investigator cannot
discontinue all IOP-lowering ocular medication(s) per the
appropriate washout schedule prior to the E1 Visit.
Related to previous or current ocular disease/condition
(either eye)
6. History of chronic, recurrent or severe inflammatory eye
disease (ie, scleritis, uveitis, herpes keratitis).
7. Ocular trauma requiring medical attention within the past
6 months prior to the Screening Visit.
8. Ocular infection or ocular inflammation within the past
3 months prior to the Screening Visit.
9. Clinically significant or progressive retinal disease such as
retinal degeneration, diabetic retinopathy, or retinal
detachment.
10. Best-corrected visual acuity (BCVA) score worse than
55 ETDRS letters (equivalent to approximately 0.60
logMAR, 20/80 Snellen, or 0.25 decimal).
11. Other severe ocular pathology (including severe dry eye),
in the opinion of the Investigator, that would preclude the
administration of a topical prostaglandin analog.
12. Intraocular surgery within the past 6 months prior to the
Screening Visit.
13. Ocular laser surgery within the past 3 months prior to the
Screening Visit.
14. Any abnormality preventing reliable applanation tonometry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate that the IOP lowering efficacy of Travoprost Ophthalmic Solution, 0.003% is equivalent to TRAVATAN® in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: Not applicable;Primary end point(s): ?Primary Efficacy <br>• IOP at Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM);Timepoint(s) of evaluation of this end point: Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ?• IOP change from baseline and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM). <br>• Percentage of patients who achieve a target IOP level < 18 mmHg at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM). <br>;Timepoint(s) of evaluation of this end point: at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).