A Phase 2 interventional study of timolol/dorzolamide combination in Glaucoma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's enrollment of 37 is below the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Drug: timolol/dorzolamide combination
Drug page: Dorzolamide-timolol combination
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Also known as: Cosopt
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
Baseline IOP
Baseline IOP was measured at \~9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline
| Milestone | Timolol/Dorzolamide |
|---|---|
| Started | 37 |
| Completed | 36 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
| mmHg | Timolol/Dorzolamide |
|---|---|
| Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. | -3.73 ± 2.28 |
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
| mmHg | Timolol/Dorzolamide |
|---|---|
| Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. | -3.22 ± 2.14 |
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
| mmHg | Timolol/Dorzolamide |
|---|---|
| Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP | -3.78 ± 2.40 |
Baseline IOP was measured at \~9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
| mmHg | Timolol/Dorzolamide |
|---|---|
| Baseline IOP | 15.60 ± 2.46 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Timolol/Dorzolamide | — | 0/37 (0%) | 24/37 (64.9%) |
| Event | Timolol/Dorzolamide |
|---|---|
| Eye irritationEye disorders | 22/37 |
| Ocular hyperaemiaEye disorders | 6/37 |
| Back painMusculoskeletal and connective tissue disorders | 2/37 |
| HeadacheNervous system disorders | 2/37 |
| RashSkin and subcutaneous tissue disorders | 2/37 |
| Age, Continuous(years) | Timolol/Dorzolamide |
|---|---|
| Mean | 56.6 ± 10.92 |
| Sex: Female, Male(Participants) | Timolol/Dorzolamide |
|---|---|
| Female | 19 |
| Male | 18 |
No study locations are listed for this record.
Plan to share: Yes — 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
Ran from Apr 2009 to primary completion in Mar 2010, 10 months.
Results were first posted in Mar 2011, 1 year after primary completion.
Of 41 industry-sponsored phase 2 interventional studies under Glaucoma, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's 10 months is close to that.
Counting every sponsor, half of 51 studies reached it within 11 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dorzolamide-timolol combination