Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

Ora, Inc.

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Tears Naturale II Ophthalmic Solution; Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534195

12-270-0001

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

• Ocular itching
• Conjunctival redness

Full description

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.

• Prednisolone phosphate
• Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age & either sex, any race
• Willing and able to follow all instructions
• Positive history of ocular allergies
• Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion criteria

• Have planned surgery during trial period
• Female currently pregnant, planning a pregnancy or lactating
• Use of disallowed medications
• Have ocular infections, or ocular conditions that could affect study parameters
• Have moderate to severe dry eye
• Have used an investigational drug or device within 30 days of start of study
• Female that is currently pregnant, planning a pregnancy or lactating

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

11 participants in 2 patient groups, including a placebo group

Prednisolone

Experimental group

Description:

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Treatment:

Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%

Placebo

Placebo Comparator group

Description:

Tears Naturale II Ophthalmic Solution, 1%

Treatment:

Drug: Tears Naturale II Ophthalmic Solution