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

Allergic Conjunctivitis Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050865
• Other study ID #: CLN-Protocol-0052
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

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