Clinical trial NCT00545064: Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.


Eligibility criteria: Inclusion Criteria:

* Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an Intra-ocular Pressure (IOP) of \> 27 mm Hg (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 mm Hg 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 mm Hg 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®)

Primary outcomes:
measure: Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score
timeFrame: Baseline to week 8
Secondary outcomes:
Other outcomes:
measure: Patient's Global Satisfaction
timeFrame: Week 8
measure: Physician's Global Satisfaction
timeFrame: Week 8
measure: Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol
timeFrame: Baseline to Week 4 and from Baseline to Week 8
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hutnik C, Neima D, Ibrahim F, Scott R, Vaillancourt J, Haine D, Sampalis JS, Bastien N, Foucart S. Tolerability and effectiveness of preservative-free dorzolamide-timolol (preservative-free COSOPT) in patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2010 Jul 21;4:581-90. doi: 10.2147/opth.s10337.