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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04050865
Other study ID # CLN-Protocol-0052
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 5, 2019
Est. completion date February 28, 2020

Study information

Verified date September 2021
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Dexamethasone, 0.4mg
Ophthalmic Insert
Device:
Placebo plug with no drug
Ophthalmic Insert

Locations

Country Name City State
United States Vision Institute Colorado Springs Colorado
United States Silverstein Eye Centers Kansas City Missouri
United States The Eye Care Institute Louisville Kentucky
United States Total Eye Care, P.A. Memphis Tennessee
United States Andover Eye Associates Raynham Massachusetts
United States Eye Associates of Texas Round Rock Texas

Sponsors (1)

Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 minutes
Primary 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
5 minutes
Primary 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
7 minutes
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