A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01525173
First received: January 31, 2012
Last updated: November 28, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Drug: 0.1% brimonidine tartrate ophthalmic solution Drug: 0.01% bimatoprost ophthalmic solution Drug: 0.2% hypromellose lubricant eye drops Drug: latanoprost 0.005% ophthalmic solution |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Tetrahydrozoline hydrochloride
Hydroxypropyl methylcellulose
Boric acid
Brimonidine tartrate
Latanoprost
Bimatoprost
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Mean Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 137 |
| Study Start Date: | January 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ALPHAGAN® P and LUMIGAN®
Subjects will apply 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only. Following latanoprost dosing, subjects will apply 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
|
Drug: 0.1% brimonidine tartrate ophthalmic solution
Subjects will apply 1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
Other Name: ALPHAGAN® P
Drug: 0.01% bimatoprost ophthalmic solution
Subjects will apply 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Name: LUMIGAN®
Drug: latanoprost 0.005% ophthalmic solution
Subjects will apply 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
|
|
Active Comparator: LUMIGAN® Alone
Subjects will apply 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only. Following latanoprost dosing, subjects will apply 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
|
Drug: 0.01% bimatoprost ophthalmic solution
Subjects will apply 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Name: LUMIGAN®
Drug: 0.2% hypromellose lubricant eye drops
Subjects will apply 1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
Other Name: GenTeal ®
Drug: latanoprost 0.005% ophthalmic solution
Subjects will apply 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ocular hypertension or glaucoma in at least 1 eye
- Visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
- Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
- Intraocular or glaucoma surgery in the past 3 months
Contacts and Locations More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01525173 History of Changes |
| Other Study ID Numbers: | GMA-LUM-11-019 |
| Study First Received: | January 31, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Tetrahydrozoline Brimonidine Latanoprost Bimatoprost Cloprostenol Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Luteolytic Agents Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on June 18, 2013