GlaucomaPhase 2NCT01254370
Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease
A Phase 2 study testing Latanoprost and Travatan Z in people with Glaucoma and Ocular Hypertension, run by Santen SAS at 1 site in United States.
Trial summary
The purpose of this study is to compare: the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Ocular Surface Disease
- What is being tested?
- Latanoprost and Travatan Z
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age at Visit 1 (IOP Screening), of either sex and any race or ethnicity.
- Be willing and able to provide written informed consent prior to any study procedures being performed.
- Be willing and able to follow all instructions and attend all study visits.
- Have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or chronic angle closure glaucoma with a patent iridotomy requiring treatment with an ocular hypertensive therapy in the study eye.
- Agree to submit to a pregnancy test at Visit 1 and at Visit 4, or not be of childbearing potential.
- Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.
Who cannot join
- Have known sensitivity or poor tolerance to latanoprost or travoprost or any other component of the study medications.
- Have any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component), ocular hypertension or chronic angle closure glaucoma with patent iridotomy in either eye.
- Have an IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 34 mmHg in either eye.
- Be currently pregnant, nursing, or planning a pregnancy during the study period; or be a woman that has a positive pregnancy test.
- Have a history of any significant ocular condition(s) in either eye that would contraindicate the use of latanoprost or travoprost, or that might affect the study conduct or the interpretation of the study results.
- Have any abnormality preventing reliable Goldmann applanation tonometry of either eye.
Show all 9Show fewer
- Have been previously non-responsive to prostaglandin analog therapy for reduction of IOP.
- Have prior (within 30 days of Visit 1) or anticipated concurrent use of an investigational drug or device during the study period.
- Have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ora (Ophthalmic Research Associates)
Andover, Massachusetts, 01810
About this study
Official title: A Phase 2, Randomized Study Evaluating the Safety and Efficacy of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® in Subjects With Glaucoma or Ocular Hypertension and Ocular Surface Disease
The purpose of this study is to compare:
- the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease.
- the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.
- Conditions
- Glaucoma, Ocular Hypertension, Ocular Surface Disease
- Being tested
- Latanoprost, Travatan Z
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
0.005%
Travatan ZDrug
0.004%
| Study group | Role | What they receive |
|---|---|---|
| Catioprost | Experimental | Not described Receives: Drug: Latanoprost |
| Travatan Z | Active comparator | Not described Receives: Drug: Travatan Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Catioprost versus Travatan Z
Efficacy measures:
- Change from baseline in Intraocular Pressure (IOP)
- Change in Ocular Surface Disease (OSD)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254370
- Sponsor's protocol ID
- NVG10E118
- Status last verified
- May 2016
- First submitted
- 29 Nov 2010
- Last updated
- 6 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Study Evaluating the Safety and Efficacy of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® in Subjects With Glaucoma or Ocular Hypertension and Ocular Surface Disease
- ClinicalTrials.gov ID
- NCT01254370
- Acronym / sponsor ID
- NVG10E118
- Conditions
- Glaucoma, Ocular Hypertension, Ocular Surface Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare:
- the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease.
- the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catioprost | Experimental | Drug: Latanoprost |
| Travatan Z | Active comparator | Drug: Travatan Z |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age at Visit 1 (IOP Screening), of either sex and any race or ethnicity.
- Be willing and able to provide written informed consent prior to any study procedures being performed.
- Be willing and able to follow all instructions and attend all study visits.
- Have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or chronic angle closure glaucoma with a patent iridotomy requiring treatment with an ocular hypertensive therapy in the study eye.
- Agree to submit to a pregnancy test at Visit 1 and at Visit 4, or not be of childbearing potential.
Key exclusion criteria (9 listed)
- Have known sensitivity or poor tolerance to latanoprost or travoprost or any other component of the study medications.
- Have any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component), ocular hypertension or chronic angle closure glaucoma with patent iridotomy in either eye.
- Have an IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 34 mmHg in either eye.
- Be currently pregnant, nursing, or planning a pregnancy during the study period; or be a woman that has a positive pregnancy test.
- Have a history of any significant ocular condition(s) in either eye that would contraindicate the use of latanoprost or travoprost, or that might affect the study conduct or the interpretation of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost0.005% | Drug | Catioprost |
| Travatan Z0.004% | Drug | Travatan Z |
Primary outcome
Efficacy of Catioprost versus Travatan Z
Time frame: 3 months
Efficacy measures: * Change from baseline in Intraocular Pressure (IOP) * Change in Ocular Surface Disease (OSD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latanoprost and Travatan Z in people with Glaucoma and Ocular Hypertension, run by Santen SAS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Catioprost versus Travatan Z (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.