Divided Dose of TRAVATAN®
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ClinicalTrials.gov Identifier: NCT01298687 |
Recruitment Status
:
Completed
First Posted
: February 18, 2011
Last Update Posted
: May 5, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Open-angle Glaucoma Ocular Hypertension | Drug: Travoprost Ophthalmic Solution, 0.00013% Drug: Travoprost Ophthalmic Solution, 0.00033% Drug: Travoprost Ophthalmic Solution, 0.001% Drug: Travoprost Ophthalmic Solution, 0.00267% Drug: Travoprost Ophthalmic Solution, 0.004% Drug: Travoprost Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Trav 0.00013%
Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
|
Drug: Travoprost Ophthalmic Solution, 0.00013%
Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
|
Experimental: Trav 0.00033%
Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
|
Drug: Travoprost Ophthalmic Solution, 0.00033%
Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
|
Experimental: Trav 0.001%
Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
|
Drug: Travoprost Ophthalmic Solution, 0.001%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
|
Experimental: Trav 0.00267%
Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
|
Drug: Travoprost Ophthalmic Solution, 0.00267%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
|
Active Comparator: TRAVATAN
Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals)
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Drug: Travoprost Ophthalmic Solution, 0.004%
Other Name: TRAVATAN®
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Placebo Comparator: Vehicle
Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
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Drug: Travoprost Vehicle
Inactive ingredients used as an active comparator
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- 24-hour Area Under the Curve (AUC) in IOP Reduction [ Time Frame: Day 5 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
- Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
- Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
- Must sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
- Current or history of ocular inflammation or infection in either eye within the past 3 months.
- Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
- Severe visual field loss.
- Cup to disc ratio greater than 0.8 in either eye.
- Intraocular surgery within the past 6 months in either eye.
- Other protocol-defined exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298687
Study Director: | Matt Walker, PhD | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01298687 History of Changes |
Other Study ID Numbers: |
C-10-081 |
First Posted: | February 18, 2011 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | July 2014 |
Keywords provided by Alcon Research:
open-angle glaucoma ocular hypertension divided dose |
Additional relevant MeSH terms:
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases Cardiovascular Diseases |
Eye Diseases Pharmaceutical Solutions Ophthalmic Solutions Travoprost Antihypertensive Agents |