A Phase 4 interventional study of Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) and Latanoprost ophthalmic solution 0.005% (XALATAN®) in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-18.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.
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This study's enrollment of 54 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
Also known as: TRAVATAN Z®
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
Also known as: XALATAN®
Comfort Immediately After Dosing
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Time frame: 5 seconds
Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.
| Milestone | Travoprost/Latanoprost |
|---|---|
| Started | 54 |
| Completed | 54 |
| Not completed | 0 |
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
| Units on a scale | Travoprost | Latanoprost |
|---|---|---|
| Comfort Immediately After Dosing | 7.8 ± 16.1 | 7.1 ± 16.2 |
Collected over Adverse events were collected for the duration of the study and 14 days post study exit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Travoprost | — | 0/54 (0%) | 0/54 (0%) |
| Latanoprost | — | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Travoprost/Latanoprost |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 24 |
| Sex: Female, Male(Participants) | Travoprost/Latanoprost |
|---|---|
| Female | 37 |
| Male | 17 |
No study locations are listed for this record.
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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