Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01%
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01464424
First received: November 1, 2011
Last updated: June 1, 2012
Last verified: June 2012
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Purpose
Subjects are dosed once daily with either TRAVATAN®Z or LUMIGAN® at 8PM for 6 weeks and then are switched for a further 6 weeks to the other product either TRAVATAN®Z or LUMIGAN®. The primary efficacy variable: To demonstrate non-inferiority in the Intraocular Pressure (IOP) lowering efficacy of travoprost 0.004% (TRAVATAN® Z) to that of bimatoprost 0.01% after 6 weeks of treatment. Secondary efficacy variable: To detect a difference in IOP lowering efficacy of travoprost 0.004% (TRAVATAN® Z) and bimatoprost 0.01% measured at individual time points post dose after 6 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Intraocular Hypertension |
Drug: travoprost 0.004% (TRAVATAN®Z) Drug: bimatoprost 0.01% (LUMIGAN) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Intraocular Pressure (IOP) lowering effect of travoprost 0.004% (TRAVATAN® Z) vs bimatoprost 0.01%. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Intraocular Pressure (IOP) lowering effect of travoprost 0.004% (TRAVATAN® Z) vs bimatoprost 0.01% measured at the individual timepoints after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 83 |
| Study Start Date: | October 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: travoprost 0.004%
travoprost 0.004% (TRAVATAN®Z)
|
Drug: travoprost 0.004% (TRAVATAN®Z)
Dosed once daily at 8:00 PM for 6 weeks
Drug: bimatoprost 0.01% (LUMIGAN)
Dosed once daily at 8:00 PM for 6 weeks
|
|
Active Comparator: bimatoprost 0.01%
bimatoprost 0.01% (LUMIGAN)
|
Drug: travoprost 0.004% (TRAVATAN®Z)
Dosed once daily at 8:00 PM for 6 weeks
Drug: bimatoprost 0.01% (LUMIGAN)
Dosed once daily at 8:00 PM for 6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be at least 18 years of age.
- Must have a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye .
- Baseline IOPs ≥ 24 and <36 mmHg in the study eye at 8 AM ± 30 min after IOP lowering medication washouts (5 days for miotics and carbonic anhydrase inhibitors, 14 days for adrenergic agonists and 28 days for β-blockers and prostaglandin analogs, and fixed combination drugs) on two separate eligibility visits.
- After the washout period, must have IOPs considered to be safe in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- In the eye that is not included in the study, the IOP should be able to be controlled on no therapy or on the study medicine alone.
- Must be willing to discontinue the use of all other IOP lowering medications prior to receiving the study medication and for the duration of the study.
- Must be able to follow instructions, self instill study article and be willing and able to attend all study visits.
- Must have best corrected visual acuity of < 20/200 in each eye.
- An Ethics Committee reviewed and approved informed consent form must be read, signed, and dated by the participating subject, as well as signed and dated by the individual obtaining the informed consent
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study
- Any abnormality preventing applanation tonometry in either eye.
- Corneal dystrophies.
- Any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Dry eye or keratoconjunctivitis sicca which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Intraocular conventional or laser surgery >3 months prior to consent
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- A history of, or at risk for uveitis or cystoid macular edema (CME).
- Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study.
- Any clinically significant, serious, or severe medical condition.
- Women of childbearing potential not using reliable means of birth control.
- Women who are pregnant or lactating
- Subjects who cannot safely undergo the washout period of 3 days ±1 day to 28 days ± 1 day prior to being enrolled/randomized.
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- Participation in any other study within 30 days prior to Screening.
- Use of any systemic (oral), injectable or topical steroids
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01464424 History of Changes |
| Other Study ID Numbers: | RDG-10-003 |
| Study First Received: | November 1, 2011 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Glaucoma Intraocular hypertension Intraocular pressure (IOP) |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases |
Travoprost Bimatoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013