GlaucomaPhase 1NCT01845038
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
A Phase 1 study testing OTX-TPa ~4µg/day over 2 mos. with natural tears drops, OTX-TPb ~3µg/day over 3 months with natural tears drops and Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug in people with Glaucoma, run by Ocular Therapeutix, Inc. at 1 site in South Africa.
Trial summary
The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- OTX-TPa ~4µg/day over 2 mos. with natural tears drops, OTX-TPb ~3µg/day over 3 months with natural tears drops and Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2013to May 2014
- Phase
- Phase 1
- 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
- Subject must be greater than or equal to 18 years of age at Screening.
- Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
- Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
- Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.
Who cannot join
- Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
- Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
- Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma
- Being tested
- OTX-TPa ~4µg/day over 2 mos. with natural tears drops, OTX-TPb ~3µg/day over 3 months with natural tears drops, Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TPa ~4µg/day over 2 mos. with natural tears dropsDrug
OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
OTX-TPb ~3µg/day over 3 months with natural tears dropsDrug
OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
Timolol Maleate (0.5%) dosed twice daily with punctum plug without drugDrug
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.
| Study group | Role | What they receive |
|---|---|---|
| OTX-TPa | Experimental | OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of ~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. Receives: Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops |
| OTX-TPb | Experimental | OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of ~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. Receives: Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops |
| Timolol | Active comparator | Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months. Receives: Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP change from baseline
Measured: 90 days
Secondary outcomes (1)
Visualization of OTX-TP punctum plug by subject
OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMay 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845038
- Sponsor's protocol ID
- OTX-12-003
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2013
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01845038
- Acronym / sponsor ID
- OTX-12-003
- Conditions
- Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 May 2013 (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 evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OTX-TPa | Experimental | Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears dropsOTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of ~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. |
| OTX-TPb | Experimental | Drug: OTX-TPb ~3µg/day over 3 months with natural tears dropsOTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of ~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. |
| Timolol | Active comparator | Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drugTimolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be greater than or equal to 18 years of age at Screening.
- Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
- Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
- Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.
Key exclusion criteria (3 listed)
- Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
- Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
- Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.
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 |
|---|---|---|
| OTX-TPa ~4µg/day over 2 mos. with natural tears dropsOTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops. | Drug | OTX-TPa |
| OTX-TPb ~3µg/day over 3 months with natural tears dropsOTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops. | Drug | OTX-TPb |
| Timolol Maleate (0.5%) dosed twice daily with punctum plug without drugTimolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed. | Drug | Timolol |
Primary outcome
Mean IOP change from baseline
Time frame: 90 days
1 secondary outcome
Visualization of OTX-TP punctum plug by subject
Time frame: 90 days
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 12 Dec 2016.
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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 Phase 1 study testing OTX-TPa ~4µg/day over 2 mos. with natural tears drops, OTX-TPb ~3µg/day over 3 months with natural tears drops and Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug in people with Glaucoma, run by Ocular Therapeutix, Inc. at 1 site in South Africa.
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 4 inclusion and 3 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 12 Dec 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 South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Mean IOP change from baseline (time frame: 90 days). 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 12 Dec 2016; AzTrials last refreshed its copy on 30 Oct 2026.