A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Status and phase
Completed
Phase 2
Conditions
Presbyopia
Treatments
Drug: AGN-199201 + AGN-190584 Combination
Drug: AGN-190584 vehicle
Drug: AGN-199201 ophthalmic solution
Drug: AGN-190584 ophthalmic solution
Drug: AGN-199201 vehicle
Details and patient eligibility
About
This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).
Enrollment
163 patients
Sex
All
Ages
40 to 50 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
Quadruple Blind
163 participants in 4 patient groups
AGN-199201 and AGN-190584 Vehicle
Experimental group
Description:
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
Treatment:
Drug: AGN-190584 vehicle
Drug: AGN-199201 + AGN-190584 Combination
Drug: AGN-199201 ophthalmic solution
Drug: AGN-199201 vehicle
Drug: AGN-190584 ophthalmic solution
AGN-199201 and AGN-190584 Dose A
Experimental group
Description:
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
Treatment:
Drug: AGN-190584 vehicle
Drug: AGN-199201 + AGN-190584 Combination
Drug: AGN-199201 ophthalmic solution
Drug: AGN-199201 vehicle
Drug: AGN-190584 ophthalmic solution
AGN-199201 and AGN-190584 Dose B
Experimental group
Description:
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
Treatment:
Drug: AGN-190584 vehicle
Drug: AGN-199201 + AGN-190584 Combination
Drug: AGN-199201 ophthalmic solution
Drug: AGN-199201 vehicle
Drug: AGN-190584 ophthalmic solution
AGN-199201 and AGN-190584 Dose C
Experimental group
Description:
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
Treatment:
Drug: AGN-190584 vehicle
Drug: AGN-199201 + AGN-190584 Combination
Drug: AGN-199201 ophthalmic solution
Drug: AGN-199201 vehicle
Drug: AGN-190584 ophthalmic solution
Trial contacts and locations
20
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Data sourced from clinicaltrials.gov
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