Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
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ClinicalTrials.gov Identifier: NCT01995136 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : July 20, 2015
Last Update Posted : October 7, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Normal Tension Glaucoma Ocular Hypertension | Drug: Travoprost Ophthalmic Solution 0.004% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: TRAVATAN Z
Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
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Drug: Travoprost Ophthalmic Solution 0.004%
benzalkonium chloride (BAC) free
Other Name: TRAVATAN Z® |
- Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 [ Time Frame: Baseline (Day 0), Week 4, Week 8, Week 12 ]IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of normal tension glaucoma.
- Must sign an Informed Consent form.
- IOP within protocol-specified range.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Pregnant and lactating women, or women who intend to become pregnant during the study period.
- Advanced and serious glaucoma, as specified in protocol.
- Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
- History of ocular trauma, intraocular surgery or laser surgery for the included eye.
- Ocular-infection and severe ocular complication.
- Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
- Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
- Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
- Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
- Use of any adrenocorticosteroids during the study period.
- Use of IOP lowering ophthalmic solution within the past 30 days.
- Regarded by doctor as not suitable for study participation.
- Other protocol-specified 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): NCT01995136
Japan | |
Alcon Japan, Ltd. | |
Tokyo, Japan |
Study Director: | Danyel Carr, MS | Alcon Japan, Ltd. |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01995136 History of Changes |
Other Study ID Numbers: |
M-13-047 UMIN000011621 ( Registry Identifier: UMIN ) |
First Posted: | November 26, 2013 Key Record Dates |
Results First Posted: | July 20, 2015 |
Last Update Posted: | October 7, 2015 |
Last Verified: | October 2015 |
Glaucoma Ocular hypertension |
Glaucoma Ocular Hypertension Low Tension Glaucoma Hypertension Vascular Diseases Cardiovascular Diseases |
Eye Diseases Optic Nerve Diseases Travoprost Ophthalmic Solutions Pharmaceutical Solutions Antihypertensive Agents |