A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X (0.006%, 0.012%, 0.024% and 0.040%) to Latanoprost 0.005% in Subjects with Open Angle Glaucoma or Ocular Hypertensio

• Conditions: Open Angle Glaucoma or Ocular Hypertension; MedDRA version: 13.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2010-022178-14-CZ
• Lead Sponsor: Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH/Bausch & Lomb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-24
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
2. Subjects must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
3. Subjects must have a diagnosis of open angle glaucoma (OAG) (including pigmentary or pseudoexfoliative) or ocular hypertension (OH) in one or both eyes.
4. Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 1 [after washout for the subjects already on treatment]):
- a mean/median IOP = 26 mm Hg at a minimum of one time point, = 24 mm Hg at a minimum of one time point, and = 22 mm Hg at one time point in the same eye and,
- mean/median IOP = 32 mm Hg in both eyes at all three measurement time points
5. Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.
6. Women of childbearing potential who have a negative urine pregnancy test result at Visit 1 (Screening), Visit 3 (Eligibility, Day 1), and Visit 6.
7. Female subjects of childbearing potential are eligible for the study but should be willing to use adequate (at least one form of) contraceptive methods as described below during the treatment period (approximately 28 days). Male subjects with partners of childbearing potential must agree to use adequate (at least one form of) contraception as described below during the treatment period (approximately 28 days).
- Acceptable contraceptive methods for female (need at least one):
? hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants,
progesterone-releasing intrauterine devices [IUDs]) initiated at least 14 days prior to the first dose of trial medication
? abstinence
? placement of a copper-containing IUD
? condom with spermicidal foam/gel/film/cream/suppository
? postmenopausal at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
? male partner who has had a vasectomy for at least 3 months
- Acceptable contraceptive methods for male subjects with partners of childbearing
potential (need at least one):
? abstinence
? vasectomy for at least 3 months
? without a vasectomy, must use a condom
8. Subjects who are able and willing to comply with all treatment and follow-up/study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects participating in any drug or device clinical investigation within 30 days prior to the Visit 1 (Screening) and/or during the period of study participation.
2. Women who are breastfeeding.
3. Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
4. Subjects with known contraindications to nitric oxide (NO) treatment (ie, history of severe hypotension, alcohol abuse, or hypersensitivity to any of the drug components).
5. Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study medication and during study visits.
6. Subjects whose central corneal thickness is greater than 590 µm in either eye.
7. Subjects with any condition that prevented reliable applanation tonometry (eg, significant corneal surface abnormalities) in either eye.
8. Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
9. Subjects with previous or active corneal disease.
10. Subjects with history of severe dry eye.
11. Subjects with monophthalmia.
12. Subjects with optic disc hemorrhage.
13. Subjects with a history of central retinal vein and artery occlusion.
14. Subjects with a history of macular edema.
15. Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
16. Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
17. Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer’s anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
18. Subjects with a diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
19. Subjects who are expected to require treatment with ocular or systemic corticosteroids.
20. Subjects who are in need of any other topical or systemic treatment of OAG or OH.
21. Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP (eg, ß-adrenergic antagonists, a-adrenergic agonists, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers) during the study period.
22. Subjects with severe dysfunction of the liver or the kidneys.
23. Subjects with active wasting disease including cancer.
24. Subjects with angina pectoris not controlled by medical or surgical treatment.
25. Subjects with severe asthma bronchiale (FEV < 70% of predicted value).
26. Subjects with hematological diseases such as aplastic anaemia, pancytopenia, or hemolytic icterus.
27. Subjects whose concomitant use of medications may interact with the safety or efficacy of a NO donating compound (eg, calcium channel blockers such as Cardiazem and vasodilators such as Isordil and BiDil).
28. Subjects who are unwilling to discontinue the use of phosphodiesterase inhibitors such as Viagra, Revatio, Levitra, or Cialis during the study.
29. Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified