Elevated Intraocular PressurePhase 3TC-002-301NCT05165290
Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
A Phase 3 study testing Latanoprost ophthalmic solution, 0.005% and TC-002 latanoprost ophthalmic solution, 0.005% in people with Elevated Intraocular Pressure, run by TearClear Corp at 20 sites in United States.
Trial summary
Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Intraocular Pressure
- What is being tested?
- Latanoprost ophthalmic solution, 0.005% and TC-002 latanoprost ophthalmic solution, 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 20 sitesUnited States
- Study dates
- 29 Nov 2021to Sep 2022
- Phase
- Phase 3
- 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
- Greater than 18 years old.
- Have been diagnosed and treated for bilateral open-angle glaucoma or ocular hypertension in both eyes.
- Currently and for at least 30 days prior to screening, are being treated with a stable dose of latanoprost ophthalmic solution or prostaglandin analog for which there is a documented and positive treatment response with either agent maintained within both eyes.
- Have best corrected visual acuity (BCVA) via Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) score +0.6 logarithm of the minimum angle of resolution (logMAR) or better in each eye.
- At Visit 1, have IOP on prostaglandin or prostaglandin analog single therapy ≤ 21mmHg, at Visit 2, have diurnal IOP between 22 and 30 mmHG, inclusive for each eye.
- In the Investigator's judgment, are able to safely discontinue current ocular hypotensive medication during the washout period.
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- Willing and able to avoid wearing contact lenses from Visit 1 (Screening) and for the duration of the trial.
- Willing and able to self-administer or have an able person available on a daily basis to assist with administration of study medication.
- Female subjects must either be incapable of pregnancy because of bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or be post-menopausal (have been amenorrheic for at least 2 years) or must use an effective (e.g., double-barrier) method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
- Willing and able to comply with all study procedures.
Who cannot join
- Causes of glaucoma other than primary open-angle glaucoma, including:
- narrow angles (3 quadrants with less than Grade 2 according to Shaffer anterior chamber angle grading system) and subjects with angle closure
- clinically significant peripheral anterior synechiae
- congenital glaucoma
- a history of angle closure in either eye
- aphakic glaucoma
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- traumatic glaucoma
- neovascular glaucoma
- pigmentary glaucoma
- pseudoexfoliative glaucoma
- drug-induced glaucoma
- Using a multi-drop treatment (other than prostaglandin or prostaglandin analog) for IOP-lowering medications.
- Advanced glaucoma or subjects with a cup/disc ratio greater than 0.8.
- Have undergone incisional IOP-lowering surgeries a placement or removal of minimally invasive glaucoma implant (MIG) in either eye.
- Have undergone non-incisional IOP-lowering surgeries within the past 6 months.
- Used anti-vascular endothelial growth factor (anti-VEGF) within 12 months of screening.
- Used intraocular, periocular or topical corticosteroids within 60 days of screening.
- Have received laser surgery for glaucoma (selective laser trabeculoplasty [SLT] or argon laser trabeculoplasty [ALT]) within 6 months of screening.
- Have uveitis, iritis or congenital aphakia.
- Are unwilling to discontinue current glaucoma medication within 30 days of the randomization (Visit 2).
- Have had intraocular or periocular surgery within the past 3 months.
- Are non-responsive to topical prostaglandins, prostamides or prostaglandin analogs in the Investigator's judgement.
- History of previous complicated cataract surgery, or previous refractive keratotomy in either eye.
- Used miotics and oral/topical carbonic anhydrase inhibitors within 5 days of screening.
- Have any known hypersensitivity to any components of the formulation or latanoprost.
- Have participated in a clinical trial for IOP-lowering investigational product or exposure to an IP within the prior 30 days.
- In the judgement of the Investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcome.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie Associates PC
Cranberry Township, Pennsylvania, 16066
Segal Drug Trials
Delray Beach, Florida, 33484
Louis M. Alpern, M.D., M.P.H., P.A.
El Paso, Texas, 79902
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Global Research Management
Glendale, California, 91204
Houston Eye Associates
Houston, Texas, 77008
Shettle Eye Research Inc.
Largo, Florida, 33773
The Eyecare Institute/Butcherton Clinical Trials
Louisville, Kentucky, 40206
Total Eye Care P.A.
Memphis, Tennessee, 38119
North Valley Eye Medical Group
Mission Hills, California, 91345
Eye Research Foundation
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Martel Eye Medical Group
Rancho Cordova, California, 95670
Rochester Ophthalmological Group PA
Rochester, New York, 14618
R&R Research LLC
San Antonio, Texas, 78229
San Antonio Eye Center
San Antonio, Texas, 78238
International Research Center
Tampa, Florida, 33603
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Michael K. Tran, MD
Westminster, California, 92683
About this study
Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States
Read the detailed description
This is a Phase 3, randomized, investigator-masked, multicenter, parallel-group trial comparing two ophthalmic solution formulations of latanoprost at a fixed dose of 0.005% administered once daily (QD) for 12 weeks.
Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States (US).
Treatment assignments will be masked to TearClear, study subjects, Investigators and site staff. Because the container closure for the investigational product is different, this study will use an unmasked dosing coordinator at each study site. All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure.
At approximately 2 select sites, approximately10% of total randomized subjects will have systemic PK labs drawn.
The study involves 7 clinic visits, including Screening (Visit 1), Randomization (Visit 2) and treatment visits (Visits 3, 5 and 7, during which ophthalmic assessments will occur and IOP will be assessed diurnally. There will be two interim IP dispensation visits (Visits 4 and 6).
- Conditions
- Elevated Intraocular Pressure
- Being tested
- Latanoprost ophthalmic solution, 0.005%, TC-002 latanoprost ophthalmic solution, 0.005%
- Keywords
- elevated IOP, open-angle glaucoma, ocular hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost ophthalmic solution, 0.005%Drug
Commercially available, FDA-approved generic latanoprost ophthalmic solution, 0.005% (LAT) without modification will be used as the active control
TC-002 latanoprost ophthalmic solution, 0.005%Drug
TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free.
| Study group | Role | What they receive |
|---|---|---|
| LAT, 0.005% | Active comparator | Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005% Receives: Drug: Latanoprost ophthalmic solution, 0.005% |
| TC-002 | Experimental | TC-002, TearClear latanoprost ophthalmic solution, 0.005% Receives: Drug: TC-002 latanoprost ophthalmic solution, 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP
Measured: Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.
Secondary outcomes (1)
Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP
Measured: Weeks 2, 6, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start29 Nov 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Intraocular PressureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TearClear Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165290
- Sponsor's protocol ID
- TC-002-301
- Acronym
- TC-002-301
- Status last verified
- May 2022
- First submitted
- 17 Dec 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT05165290
- Acronym / sponsor ID
- TC-002-301 / TC-002-301
- Conditions
- Elevated Intraocular Pressure
- Keywords
- elevated IOP, open-angle glaucoma, ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- TearClear CorpIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 21 Dec 2021 (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.
Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States
Detailed description
This is a Phase 3, randomized, investigator-masked, multicenter, parallel-group trial comparing two ophthalmic solution formulations of latanoprost at a fixed dose of 0.005% administered once daily (QD) for 12 weeks.
Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States (US).
Treatment assignments will be masked to TearClear, study subjects, Investigators and site staff. Because the container closure for the investigational product is different, this study will use an unmasked dosing coordinator at each study site. All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure.
At approximately 2 select sites, approximately10% of total randomized subjects will have systemic PK labs drawn.
The study involves 7 clinic visits, including Screening (Visit 1), Randomization (Visit 2) and treatment visits (Visits 3, 5 and 7, during which ophthalmic assessments will occur and IOP will be assessed diurnally. There will be two interim IP dispensation visits (Visits 4 and 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAT, 0.005% | Active comparator | Drug: Latanoprost ophthalmic solution, 0.005%Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005% |
| TC-002 | Experimental | Drug: TC-002 latanoprost ophthalmic solution, 0.005%TC-002, TearClear latanoprost ophthalmic solution, 0.005% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Greater than 18 years old.
- Have been diagnosed and treated for bilateral open-angle glaucoma or ocular hypertension in both eyes.
- Currently and for at least 30 days prior to screening, are being treated with a stable dose of latanoprost ophthalmic solution or prostaglandin analog for which there is a documented and positive treatment response with either agent maintained within both eyes.
- Have best corrected visual acuity (BCVA) via Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) score +0.6 logarithm of the minimum angle of resolution (logMAR) or better in each eye.
- At Visit 1, have IOP on prostaglandin or prostaglandin analog single therapy ≤ 21mmHg, at Visit 2, have diurnal IOP between 22 and 30 mmHG, inclusive for each eye.
Key exclusion criteria (27 listed)
- Causes of glaucoma other than primary open-angle glaucoma, including:
- Using a multi-drop treatment (other than prostaglandin or prostaglandin analog) for IOP-lowering medications.
- Advanced glaucoma or subjects with a cup/disc ratio greater than 0.8.
- Have undergone incisional IOP-lowering surgeries a placement or removal of minimally invasive glaucoma implant (MIG) in either eye.
- Have undergone non-incisional IOP-lowering surgeries within the past 6 months.
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 |
|---|---|---|
| Latanoprost ophthalmic solution, 0.005%Commercially available, FDA-approved generic latanoprost ophthalmic solution, 0.005% (LAT) without modification will be used as the active control | Drug | LAT, 0.005% |
| TC-002 latanoprost ophthalmic solution, 0.005%TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free. | Drug | TC-002 |
Primary outcome
Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP
Time frame: Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.
1 secondary outcome
Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP
Time frame: Weeks 2, 6, and 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Latanoprost ophthalmic solution, 0.005% and TC-002 latanoprost ophthalmic solution, 0.005% in people with Elevated Intraocular Pressure, run by TearClear Corp at 20 sites 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 10 inclusion and 27 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP (time frame: Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.). 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 25 May 2022.