Dry Eye SyndromesPhase 2NCT05814757
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
A Phase 2 study testing OTX-DED and Collagen Punctal Plug in people with Dry Eye Syndromes and Eye Diseases, run by Ocular Therapeutix, Inc. at 1 site in United States.
Trial summary
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Eye Diseases
- What is being tested?
- OTX-DED and Collagen Punctal Plug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2023to 22 May 2024
- 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
- VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
- Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
- Unanesthetized Schirmer of > 0 and ≤ 10 mm.
- Must not have used Artificial Tears during the Screening period.
- IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.
Who cannot join
- Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
- Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED
Read the detailed description
Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.
- Conditions
- Dry Eye Syndromes, Eye Diseases
- Being tested
- OTX-DED, Controlled Insertion, Collagen Punctal Plug
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-DEDDrug
0.3mg dexamethasone ophthalmic insert
Controlled InsertionDrug
Collagen Punctal Plug 0.2mm (Controlled Insertion)
Collagen Punctal PlugDrug
Collagen Punctal Plug 0.2mm (Full Insertion)
| Study group | Role | What they receive |
|---|---|---|
| OTX-DED 0.3mg | Experimental | Not described Receives: Drug: OTX-DED |
| Controlled Insertion utilizing Collagen Punctal Plug | Experimental | Not described Receives: Drug: Controlled Insertion |
| Collagen Punctal Plug (Full Insertion) | Placebo comparator | Not described Receives: Drug: Collagen Punctal Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Eye Dryness Score (visual analogue scale (VAS))
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
Measured: Change from baseline (CFB) at Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 May 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Model description
- Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- NCT05814757
- Sponsor's protocol ID
- OTX-DED-2022-C01
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2023
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT05814757
- Acronym / sponsor ID
- OTX-DED-2022-C01
- Conditions
- Dry Eye Syndromes, Eye Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 18 Apr 2023 (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.
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED
Detailed description
Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| OTX-DED 0.3mg | Experimental | Drug: OTX-DED |
| Controlled Insertion utilizing Collagen Punctal Plug | Experimental | Drug: Controlled Insertion |
| Collagen Punctal Plug (Full Insertion) | Placebo comparator | Drug: Collagen Punctal Plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
- Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
- Unanesthetized Schirmer of > 0 and ≤ 10 mm.
- Must not have used Artificial Tears during the Screening period.
- IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.
Key exclusion criteria (2 listed)
- Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
- Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.
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-DED0.3mg dexamethasone ophthalmic insert | Drug | OTX-DED 0.3mg |
| Controlled InsertionCollagen Punctal Plug 0.2mm (Controlled Insertion) | Drug | Controlled Insertion utilizing Collagen Punctal Plug |
| Collagen Punctal PlugCollagen Punctal Plug 0.2mm (Full Insertion) | Drug | Collagen Punctal Plug (Full Insertion) |
Primary outcome
Severity of Eye Dryness Score (visual analogue scale (VAS))
Time frame: Change from baseline (CFB) at Day 15
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
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 10 Jul 2024.
- 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 Phase 2 study testing OTX-DED and Collagen Punctal Plug in people with Dry Eye Syndromes and Eye Diseases, run by Ocular Therapeutix, 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 5 inclusion and 2 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 10 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Severity of Eye Dryness Score (visual analogue scale (VAS)) (time frame: Change from baseline (CFB) at Day 15). 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 10 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.