A Study of RX-10045 in the Treatment of Dry Eye Disease

C.T. Development America

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: RX-10045; Drug: Vehicle for RX-10045

Study type: Interventional

Funder types: Industry

Identifiers

NCT01675570

CTD1201

Details and patient eligibility

About

The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have a patient reported history of dry eye in both eyes
2. Presence of dry eye symptoms
3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining

Exclusion criteria

1. Known contraindications or sensitivities to study medication or its components
2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
3. Use of disallowed medication during the period indicated prior to the enrollment or during the study
4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

RX-10045 active arm

Experimental group

Description:

RX-10045 Opththalmic Solution, 0.09%

Treatment:

Drug: RX-10045

Vehicle for RX-10045 arm

Placebo Comparator group

Description:

Vehicle of RX-10045 Ophthalmic Solution

Treatment:

Drug: Vehicle for RX-10045