Elevated Intraocular Pressure (IOP)NCT04962009
Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure
A study testing Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug in people with Elevated Intraocular Pressure (IOP), run by Mati Therapeutics Inc. at 1 site in United States.
Trial summary
This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Intraocular Pressure (IOP)
- What is being tested?
- Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subject, 18 years of age or older at the time of the screening examination and has been diagnosed with bilateral OAG or OH
- A subject must be able and willing to read, comprehend and give authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
- A subject must not have taken any ocular hypertension medication(s) within the last 12 hours of the screening visit unless in the opinion of the screening physician it poses an undue risk.
- A subject must be willing to have the lower puncta of each eye inserted with a study plug
- A subject's screening visit (pre-washout) Intraocular Pressures (IOPs), measured between 8:00 and 10:00 AM, is less than 22 mmHg in both eyes
- A subject Intraocular Pressures (IOPs) are currently controlled (< 22 mm Hg) with a topical prostaglandin or in conjunction with one other topical ocular hypotensive drug, not including any fixed-combination formulations (i.e., Cosopt, Combigan, Azarga, etc.), in both eyes for at least one month
- A subject has a Best-Corrected Distance (Glasses), pinhole visual acuity of 20/100 (Snellen) or better in both eyes
- A subject has documented perimetry results within the last 6 months prior to the Screening Visit for both eyes NOTE: If perimetry measurement are older than 6 months, perform automated perimetry at the screening visit
Who cannot join
- A subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
- A subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- A subject with a known sensitivity to travoprost, fluorescein, topical anesthetic, silicone, any inactive ingredient of the Travoprost Evolute® or any other products required for study procedures
- A subject with a history of complications, AEs, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
- A subject with a history of intolerance to punctal plugs or a known sensitivity to any inactive ingredient of the punctal plug, silicone, topical anesthetic, or any other products required for the study
- A subject with structural lid abnormalities (i.e., ectropion, entropion) in either eye
Show all 18Show fewer
- A subject with an active lid disease in either eye (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment
- A subject with any clinically significant (moderate or severe) lid, conjunctival or corneal findings in either eye at the screening visit
- A subject with a history of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
- A subject who would require the use of any ocular medication(s), an over-the-counter drop(s), ointment(s) or gel(s), other than the study hypotensive medication(s) in either eye during the study period
- A subject who has had any ophthalmic surgical procedures (i.e., glaucoma laser, minimally invasive glaucoma surgery, cataract, refractive, etc.) in either eye within the last six months or will require ophthalmic surgery before completing the study
- A subject with a history of penetrating keratoplasty in either eye
- A subject requiring the use of a contact lens in either eye at any time during the study period
- A subject with advanced diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
- A subject with a history of macular edema in either eye
- A subject currently on any systemic medication [i.e., beta-blocker, carbonic anhydrase inhibitors, corticosteroids (including dermal), etc.] that may have an effect on the subject's Intraocular Pressure (IOP), or who will require its use during the study period
- A subject with an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results (e.g., autoimmune disease if the subject is on chronic medications and has ocular involvement; host-versus-graft disease)
- A subject currently participating or has participated within the last 30 days prior to the start of this study in a drug, device or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stiles Eyecare Excellence
Overland Park, Kansas, 66213
About this study
Official title: A 90-Day, Open-Label, Multi-Site, Pilot Study Evaluating the Safety and Intraocular Lowering Effect of Delivering Travoprost Using a Punctal Plug Delivery System (Evolute®) in Subjects With Elevated Intraocular Pressure
This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication.
After the six-week washout, each potential subject will return for a baseline visit. Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Read the detailed description
This is a pilot, open-label, multi-center clinical study. Each potential subject that has given HIPAA and informed consent and has meet all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. In addition, during the washout phase, each potential study subject will also discontinue the use of all prohibited systemic medications.
After the six-week washout, each potential subject will return for a baseline visit (Visit 2). Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Punctal Plug Delivery System (Evolute®). Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
- Conditions
- Elevated Intraocular Pressure (IOP)
- Being tested
- Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ugCombination product
Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
| Study group | Role | What they receive |
|---|---|---|
| Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug | Experimental | Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations. Receives: Combination Product: Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Intraocular Pressure (IOP) Change
Mean percent change in Intraocular Pressure (IOP) from baseline to days 90
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start8 Sep 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elevated Intraocular Pressure (IOP)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Travoprost Evolute (Travoprost Punctal Plug Delivery System), 166 ug
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962009
- Sponsor's protocol ID
- TGLA-2021-01
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2021
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 90-Day, Open-Label, Multi-Site, Pilot Study Evaluating the Safety and Intraocular Lowering Effect of Delivering Travoprost Using a Punctal Plug Delivery System (Evolute®) in Subjects With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT04962009
- Acronym / sponsor ID
- TGLA-2021-01
- Conditions
- Elevated Intraocular Pressure (IOP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication.
After the six-week washout, each potential subject will return for a baseline visit. Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Detailed description
This is a pilot, open-label, multi-center clinical study. Each potential subject that has given HIPAA and informed consent and has meet all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. In addition, during the washout phase, each potential study subject will also discontinue the use of all prohibited systemic medications.
After the six-week washout, each potential subject will return for a baseline visit (Visit 2). Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Punctal Plug Delivery System (Evolute®). Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Travoprost Evolute (Travoprost Punctal Plug Delivery System), 166 ug
| Arm | Type | Receives |
|---|---|---|
| Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug | Experimental | Combination Product: Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ugEach subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject, 18 years of age or older at the time of the screening examination and has been diagnosed with bilateral OAG or OH
- A subject must be able and willing to read, comprehend and give authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
- A subject must not have taken any ocular hypertension medication(s) within the last 12 hours of the screening visit unless in the opinion of the screening physician it poses an undue risk.
- A subject must be willing to have the lower puncta of each eye inserted with a study plug
- A subject's screening visit (pre-washout) Intraocular Pressures (IOPs), measured between 8:00 and 10:00 AM, is less than 22 mmHg in both eyes
Key exclusion criteria (18 listed)
- A subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
- A subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- A subject with a known sensitivity to travoprost, fluorescein, topical anesthetic, silicone, any inactive ingredient of the Travoprost Evolute® or any other products required for study procedures
- A subject with a history of complications, AEs, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
- A subject with a history of intolerance to punctal plugs or a known sensitivity to any inactive ingredient of the punctal plug, silicone, topical anesthetic, or any other products required for the study
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 |
|---|---|---|
| Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ugEach subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations. | Combination product | Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug |
Primary outcome
Mean Percent Intraocular Pressure (IOP) Change
Time frame: day 90
Mean percent change in Intraocular Pressure (IOP) from baseline to days 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
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 study testing Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug in people with Elevated Intraocular Pressure (IOP), run by Mati Therapeutics 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 8 inclusion and 18 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 13 Sep 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Intraocular Pressure (IOP) Change (time frame: day 90). 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 13 Sep 2023.