Phase 4
Completed N=76
Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Glaucoma, Primary Open Angle · Hypertension
Source: ClinicalTrials.gov NCT02796560 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Intraocular Pressure — 18.20; 18.44 mm Hg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. Patients will be randomized to receive either brand name or generic travoprost during the first visit. At the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. Patients will then receive the other formulation of travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
18.20; 18.44 | — |
| SECONDARY Comfort and Intolerance to the Drops Questionnaire |
0; 6; 5; 5; 65; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Be apt to give consent
- Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment
Exclusion Criteria
- Angle closure glaucoma or having benefited from a peripheral iridotomy
- Known allergies to travoprost or to one of the ingredients
- Current usage of other glaucoma drops other than travoprost
- Current usage of topical corticosteroids
- Pregnancy
- Breast feeding
- Monophthalmic
- Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
- Active intraocular inflammation
- Ocular surface disease that interferes with accurate measuring of the intraocular pressure
- Any clinically significant ocular disease that could interfere with the study
Data sourced from ClinicalTrials.gov (NCT02796560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.