Clinical trial NCT02796560
Conditions: Glaucoma, Primary Open Angle Ocular Hypertension
Keywords: Drugs, Generic Generic Equivalency
Sponsor: Université de Sherbrooke
Start date: 2016-07-01; Completion date: 2017-09-12
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Detailed description:

Arms: arm 1: Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks. arm 2: Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks.
Interventions: intervention 1: Brand name travoprost intervention 2: Generic travoprost
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
 
(translated from original protocol in French) 
Date of last modification 2016/06/16 
 
Research Protocol 
 
Study Title 
Randomized Controlled Crossover Trial Comparing Effectiveness and Tolerability of Generic and 
Brand Name Travoprost in Patients with Primary Open Angle Glaucoma, Normotensive Glaucoma, and 
Ocular Hypertension   
Principal investigator 
Dr. Marjorie Carbonneau 
Affiliation 
Department of Surgery, Division of Ophthalmology 
Faculty of Medicine and Health Sciences 
University of Sherbrooke 
Collaborators and their affiliation 
Dr. David Ta Kim  
Department of Surgery, Division of Ophthalmology 
Faculty of Medicine and Health Sciences 
University of Sherbrooke 
 
Dr. Patrick Daigle 
Department of Surgery, Division of Ophthalmology 
Faculty of Medicine and Health Sciences 
University of Sherbrooke 
 
Submitted to the Research Ethics Committee of the Centre Hospitalier Universitaire de 
Sherbrooke (CHUS) 
3001 12e avenue Nord 
Sherbrooke, Québec, Canada 
J1H 5N4 
 


2 
 
 
Project title : Randomized Crossover Trial Comparing Effectiveness and Tolerability of Generic and 
Brand Name Travoprost in Patients with Primary Open Angle Glaucoma, Normotensive Glaucoma, or 
Ocular Hypertension 
Date of initial submission : 2015/07/20 
1. Introduction  
Glaucoma is a chronic optic neuropathy and the leading cause of irreversible blindness in the 
world [1]. The main risk factor, and the only modifiable one, is intraocular pressure (IOP). The 
impact of poorly controlled IOP in a patient with glaucoma can lead to more rapid progression 
of the disease and blindness [2]. There are several classes of topical medication that can lower 
IOP, including beta-blockers, alphas adrenergic agonists, carbonic anhydrase inhibitors, and 
prostaglandin analogues. The most commonly prescribed first line treatment in North America 
remains prostaglandin analogues such as Travoprost, available since 2013 in generic form. 
It should be noted that in 2006, the first formulation of Travoprost (Travatan) containing 
benzalkonium chloride (BAK), a very common preservative known to irritate the ocular surface, 
was replaced by a new formulation called Travatan Z having as its agent Sofzia, an ionic 
tamponade system. The mention of the original Travoprost in this project, refers to the Travatan 
Z since the one with BAK is no longer available.  
For financial reasons, both for the patient and for society, the government promotes the 
development of generic drugs at a lower cost and encourages pharmacists to make transition 
with patients. Many patients using the original Travoprost (Travatan Z) have their treatment 
modified with generic Travoprost, often without the consent of their treating physician. In 
Canada, a generic ophthalmic drop with the same active ingredient, at the same concentration as 
the reference drug, is presumed to be bioequivalent, without the need for a comparative efficacy 
study. [3]. It is known that Latanoprost, another prostaglandin analogue, may be less stable in 
generic form than in its original version (Xalatan) under certain conditions. Variations in the 
concentration of Latanoprost and certain physicochemical properties, such as pH , the material 
of the container, the size of the drop distributed, are possible which can influence the 
bioavailability and therefore the effectiveness of the drug [4] [5] [6]. Finally, a variation of the 
non-medicinal ingredients between the 2 drugs may result in a difference in the type and 
frequency of the adverse effects, and even affect the efficacy of the product. 
In terms of therapeutic efficacy and safety of care, and for reasons of health care costs, it is 
important to demonstrate whether there is a therapeutic equivalence between generic Travoprost 
and the brand Travoprost (Travatan Z). 
 
 Is this a pilot study? 
 yes 
 no 
 
1a. Review of the literature  


3 
 
 
Currently, there are many controversies in the literature on the therapeutic equivalence of anti-
glaucoma drops and the opinion among experts differ. 
Ophthalmic drop may not be as effective as the reference drug, as the efficacy of the generic 
drug does not need to be proven for market entry in Canada [3]. 
IOP may be less well controlled with generic Latanoprost, due to variations in the 
physicochemical properties of the solution, including Latanoprost concentration. These 
variations are due, among other things, to the properties of the bottle used or the non-medicinal 
ingredients that differ from the reference medicine [4][5][6][7]. 
A 2007 study by Narayanaswarmy et al. demonstrated a difference between the generic and 
original versions of Latanoprost. This pilot study involving 30 patients in a single center in 
India seemed to demonstrate that generic Latanoprost was less effective than Xalatan in 
lowering IOP. [8]. However, this is only a small study and some questions about the reliability 
of the results have surfaced, including concerns regarding the improper storage of the generic 
Latanoprost used. 
On the other hand, several studies have shown an equivalence between the generic drug and the 
original. A randomized, double-blind study in 2011 by Diguini et al., involving 184 patients, 
demonstrated the non-inferiority of a generic version of Latanoprost compared to Xalatan.[9]. 
On the other hand, the generic version used in this study had a composition qualitatively and 
quantitatively identical to Xalatan, which is often not the case [4][10]. Another randomized 
multicentre study, by Allaire et al., included 266 patients with diagnosis of primary open angle 
glaucoma and ocular hypertension. Each patient was assigned to the generic Latanoprost group 
or the Xalatan group in a ratio of 1: 1. This study demonstrated therapeutic equivalence as well 
as the same safety profile [11]. Finally, a randomized crossover study by Golan et al. in 2015, 
compared Glautan, a generic version of Latanoprost, to Xalatan in 19 patients. The hypotensive 
effect and ocular side effect profile was comparable [12]. 
 
2. Objectives 
The primary goal was to determine if generic Sandoz-Travoprost is as effective as brand 
Travatan Z in lowering intraocular pressure, as measured using Goldmann applanation 
tonometry. 
 
The secondary goal was to determine if patients tolerate generic Sandoz-Travoprost as well as 
brand Travatan Z, using a questionnaire. 
 
3. Methodology 
a. Study Design 
Randomized controlled clinical trial, unblinded, crossover trial. 


4 
 
 
The crossover design was chosen to achieve the power required all the while limiting the 
number of patients required. 
This study was not blinded to reproduce as much as possible the real situation experienced in 
clinic by the patients and the doctors. The use of masked bottles by the pharmacy was 
considered. However, some studies have suggested that the different characteristics of drop 
bottles may have an impact on the size of the drop or the concentration of the drug after 30 
days[14]. So it was decided to use the original bottles. 
b. Information on the medication used in the study [15] 
The two drugs in the study are the original Travoprost (Travatan Z) and the generic Travoprost. 
Both are approved in Canada for hypotensive therapy in patients with GPAO or HTO. They are 
available in solution in 5 mL bottles. Since there are several companies that produce generic 
Travoprost, we would choose a version that will be the same for the entire study. 
 
i. Mechanism of action: 
Selective FP prostanoid receptor agonist that decreases intraocular pressure by increasing 
uveoscleral drainage. 
 
ii. Posology and administration: 
The recommended dosage is a drop in the affected eye or eyes once a day. The optimal effect is 
obtained by administering it in the evening. The instillation rate of Travatan Z ophthalmic 
solution (Travoprost) should not exceed 1 time / day, as it has been demonstrated that a higher 
frequency may decrease the reducing effect of intraocular pressure. 
 
The reduction in intraocular pressure begins approximately 2 hours after instillation and reaches 
its maximum after 12 hours. 
 
Storage between 2 ° C and 25 ° C recommended for stability. 
 
iii. Ingredients: 
Active ingredient: Travoprost 0.040mg/mL 
Other ingredients: Sofzia (preservation system with boric acid, propylene glycol, sorbitol, zinc 
chloride), polyoxyethylenated hydrogenated castor oil 40 and purified water. A very small 
amount of hydrochloric acid or sodium hydroxide is added to maintain the pH at the appropriate 
value. 
iv. Ocular adverse effects 
> 10% : 


5 
 
 
Changes affecting eyelashes such as increased eyelash length and increased eyelash thickness 
(61%), ocular hyperaemia (30-50%) 
1% to 10% : 
Decreased visual acuity (5% to 10%), ocular discomfort (5% to 10%), eye pain (5% to 10%), 
eye pruritus (5% to 10%), blepharitis (1% to 4%) %), impaired vision (1% to 4%), cataracts 
(1% to 4%), conjunctivitis (1% to 4%), corneal staining (1% to 4%), crusting eyelids (1% to 
4%), dry eye syndrome (1% to 4%), eyelid hyperpigmentation (periorbital, 1% to 4%), 
hyperpigmentation of the iris (1% to 4%), keratitis (1% to 4%), tearing (1% to 4%), ophthalmic 
inflammation (1% to 4%), photophobia (1% to 4%), subconjunctival hemorrhage (1% to 4%) 
Post-marketing and / or case reports : 
Bacterial keratitis (due to contamination of solution), corneal edema, cystoid macular edema, 
iritis, macular edema 
v. Systemic adverse effects 
> 10% : 
None reported 
1% to 10% : 
Cardiovascular: angina pectoris (1% to 5%), bradycardia (1% to 5%), chest pain (1% to 5%), 
hypertension (1% to 5%), hypotension (1% to 5%) 
Central nervous system: Anxiety (1% to 5%), depression (1% to 5%), headache (1% to 5%), 
pain (1% to 5%) 
Dermatological: hyperpigmentation of eyelashes, increased growth of eyelashes 
Endocrine and metabolic: hypercholesterolemia (1% to 5%) 
Gastrointestinal: dyspepsia (1% to 5%), gastrointestinal disorders (1% to 5%) 
Genitourinary: prostate disease (1% to 5%), urinary incontinence (1% to 5%), urinary tract 
infection (1% to 5%) 
Hypersensitivity: Hypersensitivity Reactions (1% to 5%) 
Infection: Infection (1% to 5%) 
Neuromuscular and skeletal: arthritis (1% to 5%), back pain (1% to 5%) 
Respiratory: Bronchitis (1% to 5%), flu-like symptoms (1% to 5%), sinusitis (1% to 5%) 
Post-marketing and / or case reports : 


6 
 
 
Asthma, tachycardia 
 
vi. Contraindications 
Allergy to prostaglandin analogues or any of the other ingredients of the product 
Being pregnant or considering pregnancy (Risk Factor C for pregnancy) 
vii. Interactions 
Non-steroidal anti-inflammatory drug: may increase the therapeutic efficacy of prostaglandins 
viii. Pharmacodynamics and pharmacokinetics 
Start of action: 2 hours 
Maximum effect: 12 hours 
Half life: 45 minutes 
ix. Inactivation and elimination 
Inactivation by the kidneys, liver and lungs. 
 
4. Study population 
a. Target population: 
All adult patients with primary open angle glaucoma, normotensive glaucoma, or ocular 
hypertension requiring pharmacological treatment seen at CHUS.  
 
5. Sample size and inclusion / exclusion criteria   
The calculation of the sample size is based on a paired t test, assuming a normal distribution of 
intraocular pressure. To demonstrate an equivalence between Travoprost original (Travatan Z) 
and generic Travoprost, a sample size of 69 patients will be required. This will detect a 
difference of 1.5mmHg with a power of 80% and an alpha of 0.05, assuming a standard 
deviation of 3.5mmHg. Assuming a loss at follow-up of 10%, the required number of patients is 
76.  
 
a. Inclusion criteria 


7 
 
 
 
To be of age 
 
Be able to consent and sign the consent form 
 
Have a diagnosis of primary open angle glaucoma, normotensive glaucoma, or ocular 
hypertension requiring pharmacological treatment 
 
b. Exclusion criteria 
 
Angle closure glaucoma 
 
Having had laser iridotomy 
 
Allergy known to Travatan or Travaprost, or to any other components of the products 
 
Use of other hypotensive ophthalmic drops (except for Travatan Z or generic Travoprost) 
 
Use of corticosteroid 
 
To be pregnant 
 
Breast-feed 
 
Being monocular 
 
Have had glaucoma surgery such as trabeculectomy and Tube implants (eg Baerveldt, 
Ahmed). Patients who have had selective laser trabeculoplasty will also be excluded. 
 
Active intraocular inflammation 
 
Ocular surface disease that may interfere with an accurate measurement of IOP 
 
Any clinically significant eye disease that may interfere with the study 
 
6. Recruitment  
The subjects will be adult patients seen in the outpatient ophthalmology clinic of the Hotel-Dieu 
de Sherbrooke, who require or already use a pharmacological treatment of Travoprost original 
(Travatan Z) or generic Travoprost and meeting the eligibility criteria. 
The subjects will be recruited at the outpatient ophthalmology clinic of the Hôtel-Dieu de 
Sherbrooke after a new consultation or a follow-up appointment. The physician resident will 
present the study to the patient, complete the consent form and obtain their signature. 
The randomization will be done beforehand. 
The only inconveniences for patients, no matter what group they are in, are the 2 follow-up 
visits, one to 3 weeks and one to 6 weeks. 
 
7. Variables and data collection  
Variable 
Type 
Method of measurement 
age 
continuous 
From the chart 
sex 
dichotomous 
From the chart 


8 
 
 
ethnic group 
categorical 
From the chart 
diagnostic 
categorical 
From the chart 
IOP 
continuous 
Goldmann applanation 
tonometry 
initial treatment 
dichotomous 
From the chart 
MD (visual fields) 
continuous 
Visual field; at the initial 
appointment 
side effects 
dichotomous 
questionnaire; at the 3 
week and 6 week 
appointments  
treatment adherence 
(number of days missed) 
continuous 
questionnaire; at the 3 
week and 6 week 
appointments 
The data will be collected by the resident in charge of the project, who will be responsible for 
their management. Registration will be in accordance with the accepted standards of 
confidentiality as described in the Act respecting health services and social services. 
We will use the Goldmann tonometer, a device on the slit lamp, to measure intraocular pressure. 
Currently, she is the gold standard for measuring intraocular pressure[13].  
The questionnaire given to patients will be a home-based questionnaire designed to check 
whether patients have had difficulty putting the drops, if they forget to put them on and if they 
have had adverse effects. The questionnaire will contain a list of side effects that patients can 
easily identify. The questionnaire will be filled verbally with the patient, and not just read and 
checked. 
The mean deflection index (MD), a parameter given by the automated visual field, is an 
accepted measure in the literature for stratifying the glaucoma stage, either mild, moderate, or 
advanced [13].  
 
 
 
 


9 
 
 
8. Study Protocol 
a. For patients who are new consultations: 
At the first visit, the patient's sociodemographic data will be collected and a complete 
ophthalmic examination will be performed. This examination will include visual acuity, 
external examination, evaluation of the cornea, anterior chamber, iris, lens, vitreous, retina and 
optic nerve (with pharmacological dilatation). intraocular pressure, gonioscopy, pachymetry and 
visual field Humphrey SITA fast 24-2. If the patient qualifies for the study, resident David Ta 
Kim will present the study. If the patient agrees, resident David Ta Kim will complete the 
consent form with the patient and get his signature. The patient will receive a bottle of original 
Travoprost (Travatan Z) or generic Travoprost according to the prior randomization. The patient 
will receive explanations on how to apply the drops. 
During the second visit, at 3 weeks +/- 3 days, the IOP will be taken by resident David Ta Kim 
at 9:00 +/- 1h. A bottle of the other medicine will be given to him. 
At the third visit at 6 weeks +/- 3 days, the IOP will be taken by resident David Ta Kim at 9:00 
+/- 1h. The patient will have completed the study and a prescription from Travoprost will be 
given. 
A questionnaire on tolerance and comfort of drops will be completed with the patient at the 
second and third visit. 
b. For patients who were already followed and treated with brand Travoprost 
(Travatan Z) or generic Travoprost: 
At the follow-up visit, if the patient qualifies for the study, resident David Ta Kim will present 
the study. If the patient agrees, resident David Ta Kim will complete the consent form with the 
patient and get his signature. The sociodemographic data of the patient will be collected and a 
complete ophthalmological examination will be performed. This examination will include 
visual acuity, external examination, evaluation of the cornea, anterior chamber, iris, lens, 
anterior vitreous, retina and optic nerve (with pharmacological dilatation). intraocular pressure, 
gonioscopy, pachymetry and visual field Humphrey SITA Standard 24-2. Gonioscopy, 
pachymetry and the visual field could be delayed if they were done in the previous 4 months. 
The patient will receive a bottle of original Travoprost (Travatan Z) or generic Travoprost 
according to the prior randomization. The patient will receive explanations on how to put the 
drops. 
During the second visit, at 3 weeks +/- 3 days, the IOP will be taken by resident David Ta Kim 
at the same time as the first visit +/- 1h. A bottle of the other medicine will be given to him. 
At the third visit at 6 weeks +/- 3 days, the IOP will be taken by resident David Ta Kim at the 
same time as the first visit +/- 1h. The patient will have finished the study and a prescription of 
his starting medication will be given. 


10 
 
 
A questionnaire on tolerance and comfort of drops will be completed with the patient at the 
second and third visit. 
 
c. For patients who drop out of the study or who are lost to follow-up: 
A loss of follow-up of 10% is anticipated so the sample size has been increased by 10%. 
d. Management of adverse effects: 
The adverse effects of these drugs are well known and are mostly minor and transient. A 
questionnaire on tolerance and comfort of drops will be completed with the patient at the second 
and third visit. If, however, a patient is very concerned about an adverse reaction, they may 
contact the ophthalmology outpatient clinic or contact the resident on call. 
Table: Summary of 3 visits by group 
 
Recruitment day 
(day 0) 
Second visit 
(at 3 weeks) 
Third visit 
(at 6 weeks) 
Group 1 
(new 
randomized 
consultation 
to 
receive 
Travatan Z 
first) 
 Presentation of the study 
to the patient 
 Obtaining consent 
 Taking of IOP 
 A bottle of Travoprost 
original (Travatan Z) 
given with instructions 
to instill a drop at 
bedtime in the eye 
reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 A bottle of generic 
Travoprost given with 
instruction to instill a 
drop at bedtime in the 
eye reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 End of the study 
Group 2 
(New 
Randomized 
Consultation 
to 
Receive 
Generic 
Travoprost 
First) 
 Presentation of the study 
to the patient 
 Obtaining consent 
 A bottle of generic 
Travoprost given with 
instruction to instill a 
drop at bedtime in the 
eye reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 A bottle of Travoprost 
original (Travatan Z) 
given with instructions 
to instill a drop at 
bedtime in the eye 
reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 End of the study 


11 
 
 
Group 3 
(Patient 
already 
randomized 
to 
receive 
Travatan Z 
first) 
 Presentation of the study 
to the patient 
 Obtaining consent 
 A bottle of Travoprost 
original (Travatan Z) 
given with instructions 
to instill a drop at 
bedtime in the eye 
reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 A bottle of generic 
Travoprost given with 
instruction to instill a 
drop at bedtime in the 
eye reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 End of the study 
Group 4 
(Patient 
already 
randomized 
to 
receive 
generic 
Travoprost 
first) 
 Presentation of the study 
to the patient 
 Obtaining consent 
 A bottle of generic 
Travoprost given with 
instruction to instill a 
drop at bedtime in the 
eye reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 A bottle of Travoprost 
original (Travatan Z) 
given with instructions 
to instill a drop at 
bedtime in the eye 
reaches 
 IOP taken by the 
resident 
 Complete the 
questionnaire on the 
comfort of the treatment 
 End of the study 
 
 
9. Data analysis 
The database will be created with Microsoft Excel. 
Statistical calculations will be done with SPSS v20. 
a. Comparison of the composition of the different groups 
A t-test will be used for continuous variables (if the data are not normally distributed, a Mann-
Whitney test will be used). 
A Chi-square test will be used for categorical variables (if the frequency is less than 5 for a 
variable, an exact Fisher test will be used). 
b. Comparison of groups at the end of the study 
A paired t test will be used if the data is normally distributed (otherwise, a Wilcoxon test will be 
used). 


12 
 
 
c. Analysis of the therapeutic effect of drugs 
An ANOVA test will be used to compare the effect of the treatments over time (an appropriate 
transformation will be applied to the data if it is not normally distributed). 
d. Comparison of adverse effects between the two treatments 
A McNeman test will be used to see if each side effect is as common with both treatments. 
e. Comparison of compliance with each treatment 
A paired t test will be used to see if patients have the same compliance for each treatment 
(Wilcoxon test if non-normal data). 
 
 
10. Limitations 
There is a potential bias of information if a patient believes that the generic is less effective, 
which could lead to a decrease in compliance or a change in dosage by the patient (eg: he could 
put it twice a day and not once). To counter this bias, the importance of abiding by the 
prescribed posology will be explained to patients. 
To avoid a learning bias, patients who start topical treatment for the first time will be told how 
to instill the drops during the initial outpatient visit. This instruction will be given by the 
resident to show the correct way to instill eye drops. A practice will then be performed using a 
new bottle of artificial tears. For those who are already taking Travoprost (Travatan Z) or 
generic Travoprost, they will be asked, during their first outpatient visit, to demonstrate how 
they instill their gout using a new bottle of artificial tears. If necessary, they will receive a short 
lesson given by the resident. 
The loss to follow-up, inevitable in a prospective study, would lead to an information bias. The 
sample size has therefore been increased by 10%. 
11. Ethical considerations 
Adverse effects related to the use of Travoprost, as well as the patient's required time and 
movement, are the only real disadvantages. Follow-up will be provided by the treating team. 
12. Anticipated benefits 
With the information obtained as to the equal or lesser effectiveness of generic Travoprost 
compared to the original Travoprost (Travatan Z), we will be able to better inform patients 
asking if the generic version of their ophthalmic drop is equivalent reference drug. If we find 
equal efficiency, the savings could be remarkable. However, if we find less efficiency, then we 


13 
 
 
can ensure that the Travoprost served to our patients is the original Travoprost (Travatan Z) and 
not a generic, ensuring better control of IOP and therefore better control of the disease.   
 
13. Dissemination of results 
We hope to publish the results of this study in a specialized journal in ophthalmology and 
present them at local, national and international conferences. The results could also be 
communicated to pharmacists, to raise awareness of the effectiveness (or lack of effectiveness) 
of generic Travoprost. 
14. Schedule 
2015/08 Submission to the Scientific and Ethics Committees 
2016/07 Start of patient recruitment 
2017/07 Data analysis 
2017/10 Writing and publication of the article 
 
15. Budget 
The cost of the study will be solely due to the ophthalmic drops delivered to patients. 
 
Sample size: 
69 
Loss to follow-up: 
10% 
Increased sample size to compensate for anticipated loss to follow-up: 
76 
Cost per bottle of generic Travoprost (5mL): 
$44.99 
Cost of generic Travoprost with taxes 
$51.74 
Bottles of generic Travoprost per patient 
1 
Total per patient (including taxes): 
$51.74 


14 
 
 
Total cost of Travoprost: 
$3,926.95 
Source of funding: 
1. CHUS Department of Surgery Research Bursary Award: $ 4000 
2. For the brand Travoprost (Travatan Z), excess unexpired samples in the clinic will be 
used 
3. No pharmaceutical company funding will be used 
 
 


15 
 
 
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Latanoprost, and Travoprost Under Simulated Daily Use. J Ocul Pharm Ther 2011;27(1):51-9.  
[6]  Morgan PV, Proniuk S, Blanchard J, Noecker RJ. Effect of Temperature and Light on the Stability of 
Latanoprost and its Clinical Relevance. J Glaucoma 2001;10:401-5.  
[7]  Cantor LB. Ophthalmic Generic Drug Approval Process: Implications for Efficacy and Safety. J 
Glaucoma 1997;6:344-9.  
[8]  Narayanaswamy A, Neog A, Baskaran M, George R, Lingam V, Desai C, Rajadhyaksha V. A 
randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in 
comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or 
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[9]  Digiuni M, Manni G, Vetrugno M, et al. An evaluation of therapeutic noninferiority of 0.005% 
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[13] Canadian Ophthalmological Society (COS).Evidence-based clinical  practice guidelines for the 
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