Study of Safety of RVL-1201 in Treatment of Blepharoptosis

RVL Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Blepharoptosis

Treatments: Other: Vehicle ophthalmic solution; Drug: RVL-1201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536949

RVL-1201-203

Details and patient eligibility

About

Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

Enrollment: 234 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female 9 years of age or older
2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
3. Must be able to self-administer study medication
4. Must be able to understand and sign an Informed Consent Form (ICF). For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.

Exclusion criteria

1. Congenital ptosis
2. Horner syndrome
3. Myasthenia gravis
4. Mechanical ptosis
5. Previous ptosis surgery
6. Resting heart rate outside the normal range
7. Hypertension with resting diastolic blood pressure
8. Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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234 participants in 2 patient groups, including a placebo group

RVL-1201 Ophthalmic Solution, 0.1%

Experimental group

Description:

RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%

Treatment:

Drug: RVL-1201

Vehicle ophthalmic solution

Placebo Comparator group

Description:

Vehicle placebo ophthalmic solution

Treatment:

Other: Vehicle ophthalmic solution