NCT00545064: DISCOVER

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

Completed Phase 4 Results posted Last updated 20 June 2017

What this trial tests

Phase 4 trial testing dorzolamide hydrochloride (+) timolol maleate in Ocular Hypertension in 176 participants. Completed in 15 September 2008.

Timeline

23 May 2007

Primary endpoint
15 September 2008

15 September 2008

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	176
Start date	23 May 2007
Primary completion	15 September 2008
Estimated completion	15 September 2008

Drugs / interventions tested

• dorzolamide hydrochloride (+) timolol maleate — full drug profile →

Conditions studied

• Ocular Hypertension — all drugs for Ocular Hypertension →
• Open Angle Glaucoma — all drugs for Open Angle Glaucoma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Ocular Hypertension or Open Angle Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score Primary · Baseline to week 8

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.

Group	Value	95% CI
Preservative-free Dorzolamide-timolol (COSOPT®) Week 4	1.7	± 16.8
Preservative-free Dorzolamide-timolol (COSOPT®) Week 8	3.2	± 20.2

Patient's Global Satisfaction Secondary · Week 8

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.

Very Satisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	79

Satisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	65

Neither Satisfied or Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	11

Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	6

Very Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	3

Missing

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	6

Physician's Global Satisfaction Secondary · Week 8

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.

Very Satisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	130

Satisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	52

Neither Satisfied or Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	5

Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	5

Very Dissatisfied

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	2

Missing

Group	Value	95% CI
Preservative-free COSOPT® at Week 8	3

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 Secondary · Baseline to Week 4 and from Baseline to Week 8

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.

Group	Value	95% CI
Preservative-free Dorzolamide-timolol (COSOPT®) Week 4	-11.7	± 5.1
Preservative-free Dorzolamide-timolol (COSOPT®) Week 8	-11.5	± 5.3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preservative-free Dorzolamide-timolol (COSOPT®)

Serious: 3/178 (2%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Preservative-free Dorzolam…
Cardiac disorders	Cardiac disorders	—
Gastrointestinal disorders	Gastrointestinal disorders	—
Eye disorders	Eye disorders	—

Most-reported serious reactions: Cardiac disorders, Gastrointestinal disorders, Eye disorders.

Data from ClinicalTrials.gov NCT00545064 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in dorzolamide hydrochloride delivery: harnessing nanotechnology for enhanced ocular drug delivery in glaucoma management.
   Pardeshi SR, Gholap AD, Hatvate NT, Gharat KD, et al · · 2024 · cited 4× · PMID 39656411 · DOI 10.1186/s11671-024-04154-x