Trial · NCT04050865
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
NCT04050865, Phase 3, Completed, Ocular Therapeutix, Inc.; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis. Trials, record NCT04050865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04050865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
- NCT number
- NCT04050865
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 96 participants, actual
- Lead sponsor
- Ocular Therapeutix, Inc.
- Conditions
- Allergic Conjunctivitis
- Interventions
- Dexamethasone, 0.4mg, Placebo plug with no drug
- First posted
- 2019-08-08
- Last updated
- 2021-10-07
- Results first posted
- 2021-10-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) | 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 |
| Primary | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | 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 |
| Primary | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) | 3 minutes | ITT Population with Multiple Imputation (MCMC) Subject Level Imputation | units on a scale | MEAN |
| PRIMARY | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | 5 minutes | units on a scale | MEAN | |
| PRIMARY | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | 7 minutes | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) | OTX-DP | 1.80 | 95% Confidence Interval 1.51 to 2.08 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) | Placebo | 2.69 | 95% Confidence Interval 2.40 to 2.98 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | OTX-DP | 1.73 | 95% Confidence Interval 1.45 to 2.00 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | Placebo | 2.72 | 95% Confidence Interval 2.44 to 3.01 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | OTX-DP | 1.72 | 95% Confidence Interval 1.43 to 2.00 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) | Placebo | 2.71 | 95% Confidence Interval 2.43 to 2.99 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTX-DP, 0.4 mg | 48 | |
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | COMPLETED | OTX-DP, 0.4 mg | 44 | |
| Overall Study | COMPLETED | Placebo | 43 | |
| Overall Study | NOT COMPLETED | OTX-DP, 0.4 mg | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Treatment Emergent Adverse Events | Eye disorders | OTX-DP | 16 | 48 | |
| other | Treatment Emergent Adverse Events | Eye disorders | Placebo | 14 | 48 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTX-DP | 0 | 48 |
| Total, all-cause mortality | Placebo | 0 | 48 |
| Total, other adverse events | OTX-DP | 16 | 48 |
| Total, other adverse events | Placebo | 14 | 48 |
| Total, serious adverse events | OTX-DP | 0 | 48 |
| Total, serious adverse events | Placebo | 0 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39328900 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OTX-DP vs Placebo: deaths from any cause | Trial comparisons |
| OTX-DP vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04050865
GET https://conductscience.org/api/trials/v1/NCT04050865/registered