Dry EyePhase 2NCT04747977

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

A Phase 2 study testing OTX-DED in people with Dry Eye, run by Ocular Therapeutix, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: OTX-DED
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: 15 sitesUnited States
Study dates: 12 Feb 2021to 22 Sep 2021
Phase: Phase 2
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

Dry Eye Disease diagnosis
VAS eye dryness severity score ≥ 40.

Who cannot join

Are unwilling to discontinue use of contact lenses
Are unwilling to withhold use of artificial tears.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Ocular Therapeutix, Inc.
Cranberry Township, Pennsylvania, 16066
Ocular Therapeutix, Inc.
Delray Beach, Florida, 33484
Ocular Therapeutix, Inc.
Indianapolis, Indiana, 46260
Ocular Therapeutix
Inglewood, California, 90301
Ocular Therapeutix
Kansas City, Missouri, 64111
Ocular Therapeutix, Inc.
Largo, Florida, 33773
Ocular Therapeutix, Inc.
League City, Texas, 77573
Ocular Therapeutix, Inc.
Memphis, Tennessee, 38119
Ocular Therapeutix, Inc
Mission Hills, California, 91345
Ocular Therapeutix, Inc.
Newport Beach, California, 92663
Ocular Therapeutix
Poughkeepsie, New York, 12603
Ocular Therapeutix, Inc.
Raleigh, North Carolina, 27603
Ocular Therapeutix, Inc.
Santa Ana, California, 92705
Ocular Therapeutix, Inc.
St Louis, Missouri, 63131
Ocular Therapeutix
Warrenville, Illinois, 60555

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Read the detailed description

Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

Conditions: Dry Eye
Being tested: OTX-DED
Keywords: dexamethasone ophthalmic insert
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OTX-DEDDrug
0.2mg dexamethasone ophthalmic insert
OTX-DEDDrug
0.3mg dexamethasone ophthalmic insert
OTX-DEDDrug
Hydrogel vehicle ophthalmic insert

Study groups in NCT04747977
Study group	Role	What they receive
OTX-DED 0.2mg	Experimental	Approximately 50 subjects Receives: Drug: OTX-DED
OTX-DED 0.3mg	Experimental	Approximately 50 subjects Receives: Drug: OTX-DED
Hydrogel Vehicle (HV)	Placebo comparator	Approximately 50 subjects Receives: Drug: OTX-DED

What is being measured

The primary outcome is the main question the study is designed to answer.

Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15).
Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
Measured: Change from baseline (Day 1) at Visit 4 (Day 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 202122 Sep 2021

First posted10 Feb 2021
Study start12 Feb 2021
Primary completion11 Aug 2021
Study completion22 Sep 2021

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 Dry EyeStudies 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 two or more groups in parallel for the duration of the study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04747977
Sponsor's protocol ID: OTX-DED-2020-201
Status last verified: Jan 2023
First submitted: 4 Feb 2021
Last updated: 22 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)
ClinicalTrials.gov ID: NCT04747977
Acronym / sponsor ID: OTX-DED-2020-201
Conditions: Dry Eye
Keywords: dexamethasone ophthalmic insert
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
Study start: 12 Feb 2021 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 22 Sep 2021 (actual)
First posted: 10 Feb 2021 (actual)
Results: Posted 22 Feb 2023

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 signs and symptoms of dry eye disease.

Detailed description

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 two or more groups in parallel for the duration of the study

Arm	Type	Receives
OTX-DED 0.2mg	Experimental	Drug: OTX-DEDApproximately 50 subjects
OTX-DED 0.3mg	Experimental	Drug: OTX-DEDApproximately 50 subjects
Hydrogel Vehicle (HV)	Placebo comparator	Drug: OTX-DEDApproximately 50 subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Dry Eye Disease diagnosis
VAS eye dryness severity score ≥ 40.

Key exclusion criteria (2 listed)

Are unwilling to discontinue use of contact lenses
Are unwilling to withhold use of artificial tears.

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-DED0.2mg dexamethasone ophthalmic insert	Drug	OTX-DED 0.2mg
OTX-DED0.3mg dexamethasone ophthalmic insert	Drug	OTX-DED 0.3mg
OTX-DEDHydrogel vehicle ophthalmic insert	Drug	Hydrogel Vehicle (HV)

Primary outcome

Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
Time frame: Change from baseline (Day 1) at Visit 4 (Day 15)
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.

Results and safety

Results posted to the registry on 22 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert	57	54
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert	57	56
Hydrogel Vehicle (HV) Intracanalicular Insert	58	55

Primary outcome: Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).

Time frame: Change from baseline (Day 1) at Visit 4 (Day 15). Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert n = 55	OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert n = 56	Hydrogel Vehicle (HV) Intracanalicular Insert n = 55
Value	-0.51 (-0.65 to -0.37)	-0.43 (-0.57 to -0.30)	-0.21 (-0.35 to -0.07)

Population analysed: mITT population: CFB in Photographic Assessment of Bulbar Conjunctival Hyperemia in the Worst Zone (highest grading score at baseline among nasal, temporal, and frontal zones) of Study Eye at Day 15

Adverse events

Time frame: Through study completion, an average of 10 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert	0 of 55 (0%)	5 of 55 (9.1%)	0 of 55
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert	0 of 56 (0%)	10 of 56 (17.9%)	0 of 56
Hydrogel Vehicle (HV) Intracanalicular Insert	2 of 55 (3.6%)	6 of 55 (10.9%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

15 sites 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 in people with Dry Eye, run by Ocular Therapeutix, Inc. at 15 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 2 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 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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. 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?

Yes. Results are posted in the registry (first posted 22 Feb 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?

Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). (time frame: Change from baseline (Day 1) at Visit 4 (Day 15)). 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 NCT04747977.

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 22 Feb 2023.