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Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED) (DISCOVER)

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

dorzolamide hydrochloride (+) timolol maleate

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®)

Sites / Locations

Outcomes

Primary Outcome Measures

Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score

GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT00545064

First Posted

October 16, 2007

Last Updated

May 25, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00545064

Brief Title

Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)

Acronym

DISCOVER

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

May 23, 2007 (Actual)

Primary Completion Date

September 15, 2008 (Actual)

Study Completion Date

September 15, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dorzolamide hydrochloride (+) timolol maleate

Other Intervention Name(s)

MK0507A, Cosopt

Intervention Description

dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment

Primary Outcome Measure Information:

Title

Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score

Description

Time Frame

Baseline to week 8

Other Pre-specified Outcome Measures:

Title

Patient's Global Satisfaction

Description

At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.

Time Frame

Week 8

Title

Physician's Global Satisfaction

Description

At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.

Time Frame

Week 8

Title

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

Description

IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.

Time Frame

Baseline to Week 4 and from Baseline to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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®)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

20668720

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.

Results Reference

result

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Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)

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