Health Condition 1: null- Glaucoma Health Condition 2: H42- Glaucoma in diseases classified elsewhere
Conditions
Interventions
Intervention1: Latanoprost 0.005% and Timolol 0.5%: Once daily for 6 weeks
Control Intervention1: Xalatan® and Timoptic®: Xalatan® once daily
Timoptic® twice daily
Control Intervention2: Xalatan®
: Once daily
Control Intervention3: Timoptic®
: Twice daily
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women aged ≥18 years. 2. Diagnosis of OHT or OAG. Pseudoexfoliation or pigment dispersion component acceptable. 3. Unmedicated IOP more than or equal to 24 mm Hg and less than or equal to 36 mm Hg in one or both eyes at eligibility visit. 4. Willing and able to give written informed consent. 5. Best corrected visual acuity 6/ 60 or better. 6. Visual field defect fulfilling following criteria a. Humphrey SITA: Mean deviation better than -20 dB or Octopus: Mean defect score better than 13 dB or Medmont: Average defect score better than - 17 dB. b. No central point depressed to 0 dB. 7. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 3 months prior to study entry and through the duration of the study; or willing to abstain through the duration of the study; or postmenopausal for at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) with a negative urine pregnancy test. 8. Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patient waits a minimum of 15 minutes following drug instillation before reinserting the lenses. Patients who wear contact lenses will be instructed to wear or bring their glasses with them on study visit days
Exclusion criteria
Exclusion criteria: 1. History of allergic hypersensitivity or poor tolerance to any of the components of the preparations used in this study. 2. Known lack of ocular hypotensive response to topical ophthalmic prostaglandin analogs or beta blockers (in the opinion of the investigator). 3. Intraocular conventional surgery or laser surgery within the past six months. 4. Refractive surgery in study eye (e.g. radial keratotomy, PRK, LASIK, etc.) within the past 3 months. 5. Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy. 6. Ocular trauma within the past 3 months. 7. Progressive retinal or optic nerve disease apart from glaucoma. 8. Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye. 9. History of chronic or recurrent severe inflammatory eye disease. 10. Other than ocular hypotensive medications, which must be washed out according to the provided schedule, ocular medication of any kind (with the exception of lubricating drops for dry eye) within 30 days of baseline. 11. Any abnormality preventing stable applanation tonometry. 12. Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber. 13. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe. 14. Any clinically significant finding on physical exam or ECG or laboratory investigation. 15. History of or current evidence of severe, unstable, or uncontrolled pulmonary, cardiovascular (e.g. COPD, asthma, sinus bradycardia, cardiogenic shock, second or third degree atrioventricular block, cardiac failure, clinically relevant angina, uncontrolled hypertension), renal or hepatic disease or any other systemic disease that might preclude the use of a beta-adrenergic blocking agent. 16. History of significant renal, hepatic, cardiovascular, metabolic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or any other significant medical illness or disorder which in the judgement of the investigator, could interfere with the study or require treatment(s) which might interfere with study. 17. History of non-compliance to medical regimens or unwilling to comply with the study protocol. 18. Participation in another clinical study within the last thirty (30) days. 19. Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean IOP.Timepoint: At week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event 2. Conjunctival hyperemia, ocular signs (cornea, lens, iris, anterior chamber), visual acuity, dilated fundoscopy (retina, macula, choroids, optic nerve, vitreous, cup-disc ratio) 3. Vital signs: Heart rate and Blood pressure (sitting) 4. 12-lead ECGTimepoint: At week 6 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd.
Outcome results
None listed