Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
Keywords
Drugs, Generic, Generic Equivalency
Brief 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.
Interventions
DRUGBrand name travoprost
Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
DRUGGeneric travoprost
Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure | After 3 weeks of either the brand name or generic travoprost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort and Intolerance to the Drops Questionnaire | After 3 weeks of either the brand name or generic travoprost | Patients will be asked about: 1. Difficulties related to administration of the drops 2. Compliance to the drops 3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brand Name Travoprost First, Then Generic Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. | 34 |
| Generic Travoprost First, Then Brand Name Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. | 36 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Generic Travoprost First, Then Brand Name | Brand Name Travoprost First, Then Generic |
|---|---|---|---|
| Age, Continuous | 67.50 years STANDARD_DEVIATION 12.16 | 68.53 years STANDARD_DEVIATION 11.22 | 66.32 years STANDARD_DEVIATION 13.22 |
| Baseline intraocular pressure | 24.50 mm Hg | 23.50 mm Hg | 26.25 mm Hg |
| Diagnosis Normal tension glaucoma | 4 Participants | 4 Participants | 0 Participants |
| Diagnosis Ocular hypertension | 13 Participants | 6 Participants | 7 Participants |
| Diagnosis Primary open angle glaucoma | 53 Participants | 26 Participants | 27 Participants |
| Mean deviation on visual field testing | -1.66 decibels | -2.05 decibels | -1.12 decibels |
| Number of Treatment Naive Participants | 58 Participants | 30 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 35 Participants | 34 Participants |
| Region of Enrollment Canada | 70 participants | 36 participants | 34 participants |
| Sex: Female, Male Female | 32 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 38 Participants | 24 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 76 |
| other Total, other adverse events | 1 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 |
Outcome results
Primary
Intraocular Pressure
Time frame: After 3 weeks of either the brand name or generic travoprost
Population: There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brand Name Travoprost | Intraocular Pressure | 18.20 mm Hg | Standard Deviation 3.41 |
| Generic Travoprost | Intraocular Pressure | 18.44 mm Hg | Standard Deviation 3.48 |
Secondary
Comfort and Intolerance to the Drops Questionnaire
Patients will be asked about: 1. Difficulties related to administration of the drops 2. Compliance to the drops 3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash
Time frame: After 3 weeks of either the brand name or generic travoprost
Population: There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Mild | 7 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Severe | 4 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Absent | 59 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Mild | 13 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Severe | 1 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Severe | 0 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Mild | 10 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Absent | 56 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Absent | 59 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Mild | 13 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Severe | 3 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Severe | 8 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Mild | 4 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Absent | 65 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Absent | 63 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Mild | 16 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Absent | 53 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Mild | 22 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Absent | 46 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Absent | 44 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Mild | 5 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Severe | 0 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Severe | 4 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Mild | 1 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Severe | 1 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Absent | 69 Participants |
| Brand Name Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Severe | 4 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Absent | 69 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Severe | 6 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Mild | 5 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you have difficulties with the treatment? | Absent | 59 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Severe | 3 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Mild | 16 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did you feel a burning sensation when administerin | Absent | 51 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Severe | 0 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Mild | 12 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your vision get blurry when administering the | Absent | 58 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Severe | 8 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Mild | 20 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Did your eyes get red when administering the drops | Absent | 42 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Severe | 3 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Mild | 10 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Are your eyes dry? | Absent | 57 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Severe | 2 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Mild | 10 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get tearing or secretions in your eyes? | Absent | 58 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Severe | 0 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Mild | 7 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | When you feel pain in your eyes when administering | Absent | 63 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Severe | 0 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Mild | 27 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do your eyes itch when administering the drops? | Absent | 43 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Severe | 0 Participants |
| Generic Travoprost | Comfort and Intolerance to the Drops Questionnaire | Do you get a rash on the skin around your eyes? | Mild | 1 Participants |