A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Allergan

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: AGN-190584 Vehicle; Drug: AGN-199201 Vehicle; Drug: AGN-190584 ophthalmic solution; Drug: AGN-199201 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02780115

199201-010

Details and patient eligibility

About

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Enrollment: 151 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living

Exclusion criteria

• Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
• Corneal abnormalities in either eye that interfere with visual acuity
• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
• Diagnosis of glaucoma or ocular hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 5 patient groups

Cohort 1: Vehicle Control

Experimental group

Description:

Vehicle dosed in both eyes administered once daily during office visits 1 through 5.

Treatment:

Drug: AGN-190584 Vehicle

Drug: AGN-199201 Vehicle

Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A

Experimental group

Description:

Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.

Treatment:

Drug: AGN-190584 ophthalmic solution

Drug: AGN-199201 ophthalmic solution

Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B

Experimental group

Description:

Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.

Treatment:

Drug: AGN-190584 ophthalmic solution

Drug: AGN-199201 ophthalmic solution

Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C

Experimental group

Description:

Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.

Treatment:

Drug: AGN-190584 ophthalmic solution

Drug: AGN-199201 ophthalmic solution

Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C

Experimental group

Description:

Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.

Treatment:

Drug: AGN-190584 ophthalmic solution

Drug: AGN-190584 Vehicle

Drug: AGN-199201 Vehicle

Drug: AGN-199201 ophthalmic solution