Glaucoma; DrugsPhase 4NCT04178863
CATS Tonometer IOP Reduction Latanoprost Verses Timolol
A Phase 4 study testing CATS Tonometer and Latanoprost in people with Glaucoma; Drugs, run by Intuor Technologies, Inc. at 1 site in United States.
Trial summary
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism Read more about this study
- Who is it for?
- Ages 18 to 101 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma; Drugs
- What is being tested?
- CATS Tonometer and Latanoprost
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Dec 2019
- Phase
- Phase 4
- 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 to 101 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Male and female patients, at least 18 years of age
- Subject has a clear understanding and agrees to all the conditions of the informed consent form
Who cannot join
- Subjects shall be selected in accordance with the following exclusion criteria
- Subject has undergone ocular surgery within the last 3 months
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- Pregnant or nursing women
- Those who have had corneal surgery including corneal laser surgery
- Microphthalmos
Show all 11Show fewer
- Buphthalmos
- Severe Dry eyes
- Lid squeezers - blepharospasm
- Nystagmus
- corneal or conjunctival infection.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arizona Eye Consultants
Tucson, Arizona, 85710
Sean McCafferty, MD, 520-400-4255, sjmccafferty66@hotmail.com
About this study
Official title: Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism
Read the detailed description
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.
- Conditions
- Glaucoma; Drugs
- Being tested
- CATS Tonometer, Latanoprost
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATS TonometerDevice
Also called latanoprost v. timolol
latanoprost vs. timolol
LatanoprostDrug
latanoprost IOP reduction
| Study group | Role | What they receive |
|---|---|---|
| lataprost | Active comparator | latanoprost use Receives: Device: CATS Tonometer |
| timolol | Active comparator | timolol group Receives: Device: CATS Tonometer; Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jul 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma; DrugsStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178863
- Sponsor's protocol ID
- 2019004
- Status last verified
- Nov 2019
- First submitted
- 23 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Radcliffe N, Berdahl J, Ibach M, Schweitzer J, Levine J, McCafferty S. Improved Efficacy of Topical Latanoprost 0.005% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism. Clin Ophthalmol. 2020 Aug 10;14:2245-2253. doi: 10.2147/OPTH.S264055. eCollection 2020.
PubMed 32884231
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism
- ClinicalTrials.gov ID
- NCT04178863
- Acronym / sponsor ID
- 2019004
- Conditions
- Glaucoma; Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Nov 2019 (actual)
- 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.
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism
Detailed description
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lataprost | Active comparator | Device: CATS Tonometerlatanoprost use |
| timolol | Active comparator | Device: CATS Tonometer, Drug: Latanoprosttimolol group |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Male and female patients, at least 18 years of age
Key exclusion criteria (11 listed)
- Subjects shall be selected in accordance with the following exclusion criteria
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 |
|---|---|---|
| CATS TonometerAlso: latanoprost v. timolollatanoprost vs. timolol | Device | lataprost, timolol |
| Latanoprostlatanoprost IOP reduction | Drug | timolol |
Primary outcome
IOP reduction
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 32884231Radcliffe N, Berdahl J, Ibach M, Schweitzer J, Levine J, McCafferty S. Improved Efficacy of Topical Latanoprost 0.005% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism. Clin Ophthalmol. 2020 Aug 10;14:2245-2253. doi: 10.2147/OPTH.S264055. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CATS Tonometer and Latanoprost in people with Glaucoma; Drugs, run by Intuor Technologies, Inc. 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP reduction (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178863, which also lists 1 linked publication.
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 26 Nov 2019.