This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
599
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Time frame: Baseline, Week 2 & Week 6
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Time frame: approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GMC, Srikakulam
Srikakulam, Andhra Pradesh, India
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
Visakhapatnam, Andhra Pradesh, India
Rising Retina Clinic
Ahmedabad, Gujarat, India
Bhavna Super speciality Eye care
Surat, Gujarat, India
Dr. BR Ambedkar Medical College and hospital
Bangalore, Karnataka, India
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, India
K R Hospital, Mysore Medical College and Research Institute
Mysuru, Karnataka, India
Shanti Saroj Netralay
Miraj, Maharashtra, India
Omkar Eye Care Center
Mumbai, Maharashtra, India
...and 30 more locations