Trial · NCT02445326
OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
NCT02445326, Phase 3, Completed, Ocular Therapeutix, Inc.; results first posted 2018-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis. Trials, record NCT02445326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02445326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
- NCT number
- NCT02445326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 73 participants, actual
- Lead sponsor
- Ocular Therapeutix, Inc.
- Conditions
- Chronic Allergic Conjunctivitis
- Interventions
- Dexamethasone, Placebo Vehicle
- First posted
- 2015-05-15
- Last updated
- 2018-03-29
- Results first posted
- 2018-03-29
Source ClinicalTrials.gov
Registered outcomes6
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 | 3 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
| Primary | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 5 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
| Primary | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 7 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 7 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 15 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 20 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None |
Source ClinicalTrials.gov
Outcomes6
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 | 3 minutes | units on a scale | MEAN | |
| PRIMARY | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 5 minutes | units on a scale | MEAN | |
| PRIMARY | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 7 minutes | units on a scale | MEAN | |
| PRIMARY | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 7 minutes | units on a scale | MEAN | |
| PRIMARY | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 15 minutes | units on a scale | MEAN | |
| PRIMARY | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 20 minutes | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
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 | OTX-DP | 1.68 | Standard Deviation 1.032 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Placebo Vehicle | 2.66 | Standard Deviation 0.861 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | OTX-DP | 1.87 | Standard Deviation 1.040 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Placebo Vehicle | 2.74 | Standard Deviation 0.690 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | OTX-DP | 1.70 | Standard Deviation 0.938 | units on a scale | |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Placebo Vehicle | 2.74 | Standard Deviation 0.679 | units on a scale | |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | OTX-DP | 1.52 | Standard Deviation 0.641 | units on a scale | |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Placebo Vehicle | 1.80 | Standard Deviation 0.764 | units on a scale | |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | OTX-DP | 1.48 | Standard Deviation 0.698 | units on a scale | |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Placebo Vehicle | 1.75 | Standard Deviation 0.786 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTX-DP | 35 | |
| Overall Study | STARTED | Placebo Vehicle | 38 | |
| Overall Study | COMPLETED | OTX-DP | 33 | |
| Overall Study | COMPLETED | Placebo Vehicle | 37 | |
| Overall Study | NOT COMPLETED | OTX-DP | 2 | |
| Overall Study | NOT COMPLETED | Placebo Vehicle | 1 |
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 | Adverse Events | General disorders | OTX-DP | 3 | 35 | 4 |
| other | Adverse Events | General disorders | Placebo Vehicle | 4 | 38 | 7 |
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 | 35 |
| Total, all-cause mortality | Placebo Vehicle | 0 | 38 |
| Total, other adverse events | OTX-DP | 3 | 35 |
| Total, other adverse events | Placebo Vehicle | 4 | 38 |
| Total, serious adverse events | OTX-DP | 0 | 35 |
| Total, serious adverse events | Placebo Vehicle | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 Vehicle: deaths from any cause | Trial comparisons |
| OTX-DP vs Placebo Vehicle: 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/NCT02445326
GET https://conductscience.org/api/trials/v1/NCT02445326/registered