Allergic ConjunctivitisPhase 3NCT04050865

A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

A Phase 3 study testing Dexamethasone, 0.4mg in people with Allergic Conjunctivitis, run by Ocular Therapeutix, Inc. at 6 sites in United States.

Completed

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

Official record

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Trial summary

The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Dexamethasone, 0.4mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 6 sitesUnited States
Study dates: 5 Aug 2019to 28 Feb 2020
Phase: Phase 3
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

Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Who cannot join

History of refractive surgery (including LASIK procedures) within the past 2 years
History of retinal detachment, diabetic retinopathy, or active retinal disease
Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
History of IOP increase as a result of steroid treatment
A female who is currently pregnant, planning a pregnancy, or lactating

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Vision Institute
Colorado Springs, Colorado, 80907
Silverstein Eye Centers
Kansas City, Missouri, 64133
The Eye Care Institute
Louisville, Kentucky, 40206
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Andover Eye Associates
Raynham, Massachusetts, 02767
Eye Associates of Texas
Round Rock, Texas, 78681

Other trials in United States

About this study

Official title: CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)

Conditions: Allergic Conjunctivitis
Being tested: Dexamethasone, 0.4mg, Placebo plug with no drug
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

Dexamethasone, 0.4mgDrug
Also called OTX-DP
Ophthalmic Insert
Placebo plug with no drugDevice
Ophthalmic Insert

Study groups in NCT04050865
Study group	Role	What they receive
OTX-DP	Experimental	Not described Receives: Drug: Dexamethasone, 0.4mg
Placebo	Placebo comparator	Not described Receives: Device: Placebo plug with no drug

What is being measured

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

Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed
Measured: 3 minutes
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments;
0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed
Measured: 5 minutes
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments;
0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed
Measured: 7 minutes

Timeline

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

5 Aug 201928 Feb 2020

First posted8 Aug 2019
Study start5 Aug 2019
Primary completion28 Feb 2020
Study completion28 Feb 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Allergic ConjunctivitisStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050865
Sponsor's protocol ID: CLN-Protocol-0052
Status last verified: Sep 2021
First submitted: 7 Aug 2019
Last updated: 7 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Kenyon K, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RH, Gomes PJ, Reilly E, Vantipalli S, Cheung MW, Goldstein MH. A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024 Sep 21;18:2671-2684. doi: 10.2147/OPTH.S476419. eCollection 2024.
PubMed 39328900

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 Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
ClinicalTrials.gov ID: NCT04050865
Acronym / sponsor ID: CLN-Protocol-0052
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
Study start: 5 Aug 2019 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 8 Aug 2019 (actual)
Results: Posted 7 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OTX-DP	Experimental	Drug: Dexamethasone, 0.4mg
Placebo	Placebo comparator	Device: Placebo plug with no drug

Who may qualify

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

Key inclusion criteria (2 listed)

Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Key exclusion criteria (5 listed)

History of refractive surgery (including LASIK procedures) within the past 2 years
History of retinal detachment, diabetic retinopathy, or active retinal disease
Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
History of IOP increase as a result of steroid treatment
A female who is currently pregnant, planning a pregnancy, or lactating

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
Dexamethasone, 0.4mgAlso: OTX-DPOphthalmic Insert	Drug	OTX-DP
Placebo plug with no drugOphthalmic Insert	Device	Placebo

Primary outcome

Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)
Time frame: 3 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
Time frame: 5 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
Time frame: 7 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

Results and safety

Results posted to the registry on 7 Oct 2021, 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-DP, 0.4 mg	48	44
Placebo	48	43

Primary outcome: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)

Time frame: 3 minutes. Mean (95% Confidence Interval). Unit: units on a scale

Measure	OTX-DP n = 48	Placebo n = 48
Value	1.80 (1.51 to 2.08)	2.69 (2.40 to 2.98)

Population analysed: ITT Population with Multiple Imputation (MCMC) Subject Level Imputation

Primary outcome: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)

Time frame: 5 minutes. Mean (95% Confidence Interval). Unit: units on a scale

Measure	OTX-DP n = 48	Placebo n = 48
Value	1.73 (1.45 to 2.00)	2.72 (2.44 to 3.01)

Primary outcome: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)

Time frame: 7 minutes. Mean (95% Confidence Interval). Unit: units on a scale

Measure	OTX-DP n = 48	Placebo n = 48
Value	1.72 (1.43 to 2.00)	2.71 (2.43 to 2.99)

Adverse events

Time frame: 30 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTX-DP	0 of 48 (0%)	16 of 48 (33.3%)	0 of 48
Placebo	0 of 48 (0%)	14 of 48 (29.2%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39328900Kenyon K, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RH, Gomes PJ, Reilly E, Vantipalli S, Cheung MW, Goldstein MH. A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024 Sep 21;18:2671-2684. doi: 10.2147/OPTH.S476419. eCollection 2024.

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
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Recruiting
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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.

6 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 Dexamethasone, 0.4mg in people with Allergic Conjunctivitis, run by Ocular Therapeutix, Inc. at 6 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 5 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

Yes. Results are posted in the registry (first posted 7 Oct 2021). 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?

Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) (time frame: 3 minutes). The study lists 3 primary outcomes in all. 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 NCT04050865, which also lists 1 linked publication.

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 7 Oct 2021.