| October 16, 2007 |
| September 8, 2008 |
| May 2007 |
| July 2008 (final data collection date for primary outcome measure) |
| Change in the incidence and severity of non-visual ocular symptoms as measured by the Glaucoma Symptom Scale (GSS) SYMP-6 scale at baseline and after 12 weeks of treatment with preservative free cosopt [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ] |
| Change in the incidence and severity of non-visual ocular symptoms as measured by the Glaucoma Symptom Scale (GSS) SYMP-6 scale at baseline and after 12 weeks of treatment with preservative free cosopt |
| Complete list of historical versions of study NCT00545064 on ClinicalTrials.gov Archive Site |
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| Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension |
| A Multicenter, Open-Label Study To Evaluate The Tolerability Of Preservative Free Dorzolamide-Timolol Therapy In Patients Untreated With Open-Angle Glaucoma Or Ocular Hypertension And Dry Eye(S) |
To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes. |
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| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
- Ocular Hypertension
- Open Angle Glaucoma
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| Drug: dorzolamide hydrochloride (+) timolol maleate |
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| Completed |
| 170 |
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| July 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an IOP of > 27 mmHg (in at least one eye) and a baseline GSS SYMP-6 total score of 75 or less
- Patient is male or a female who is highly unlikely to conceive
- Patient has been recently diagnosed and is presently untreated for open-angle glaucoma or ocular hypertension with an IOP of at least 27 mmHg in at least one eye (patient's worse eye)
- Patient already diagnosed with open-angle glaucoma or ocular hypertension and untreated for at least 30 days are eligible for the study if they have an IOP of 27 mmHg or more in at least one eye
Exclusion Criteria:
- A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk by administering preservative free dorzolamide-timolol (preservative-free Cosopt®)
- The presence of any fundus pathology likely to change during the study or to influence IOP (background of diabetic retinopathy is permitted)
- Any contraindication to the use of preservative-free Cosopt® including:
- bronchospasm, including bronchial asthma or a history of bronchial asthma or chronic obstructive pulmonary disease, sinus bradycardia, second or third degree AV block, cardiac failure (grade III and IV), cardiogenic shock, severe renal impairment (serum creatinine > 150 umol/L or creatinine clearance < 30 ml/min)
- Patient on:
- carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known to affect the IOP, e.g. clonidine, corticosteroids, oral beta-blocking agents. patient on a non-glaucoma medication that contains a preservative agent, i.e. benzalkonium chloride, benzododecinium bromide or stabilized oxychloro complex
- Patient with hypersensitivity to any component of preservative free dorzolamide-timolol (preservative-free Cosopt®)
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00545064 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_026, MK0507A-152 |
| Merck |
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| Study Director: |
Medical Monitor |
Merck |
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| Merck |
| September 2008 |
