This study is designed to see how safe and effective a new eye drop, called Reformulated PG324, is for lowering eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).
About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
489
Investigational ophthalmic solution
Commercially available ophthalmic solution
Mean Intraocular Pressure at each timepoint post-randomization
Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint.
Time frame: Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy
The subject will undergo a slit lamp examination at all visits, except for dispensing visits. The presence of moderate to severe conjunctival hyperemia (redness) will be recorded.
Time frame: Up to Month 3/study exit
Proportion of subjects with conjunctival hyperemia adverse events
Occurrences of conjunctival hyperemia (redness) adverse events, either subject or investigator reported, will be recorded at each visit.
Time frame: Up to Month 3/study exit
Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization
Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint.
Time frame: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization
Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint.
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Trinity Research Group
Dothan, Alabama, United States
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Phoenix, Arizona, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
United Medical Research Institute
Inglewood, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
Central Florida Eye Specialists
DeLand, Florida, United States
Glaucoma Specialists of South Florida
Delray Beach, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
...and 20 more locations
Time frame: Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Mean TSS-IOP scores at Month 3
The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered.
Time frame: Month 3
Mean Changes in TSS-IOP scores from Screening to Month 3
The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered.
Time frame: Month 3