Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

• Sponsor: Université de Sherbrooke (Other)
• Overall Status: Completed
• CT.gov ID: NCT02796560
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.4
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: Brand name travoprost; Drug: Generic travoprost	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Crossover Trial Comparing the Hypotensive Effect of Generic Travoprost With That of the Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Sep 12, 2017
• Actual Study Completion Date: Sep 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brand name travoprost 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.	Drug: Brand 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.; Other Names: Travatan Z
Experimental: Generic travoprost 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.	Drug: Generic 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.; Other Names: Travoprost

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [After 3 weeks of either the brand name or generic travoprost]

Secondary Outcome Measures

1. Comfort and Intolerance to the Drops Questionnaire [After 3 weeks of either the brand name or generic travoprost]

   Patients will be asked about: Difficulties related to administration of the drops Compliance to the drops Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hotel-Dieu de Sherbrooke (CHUS)	Sherbrooke	Quebec	Canada	J1G 2E8

Sponsors and Collaborators

• Université de Sherbrooke

Investigators

• Principal Investigator: Marjorie Carbonneau, MD, FRCS(C), Université de Sherbrooke, Hôtel Dieu de Sherbrooke

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 16, 2016

More Information

Publications

None provided.

• Responsible Party: Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT02796560
• Other Study ID Numbers: 2016-1164
• First Posted: Jun 10, 2016
• Last Update Posted: Dec 1, 2020
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Université de Sherbrooke: Drugs, Generic; Generic Equivalency
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost

Study Results

Participant Flow

Arm/Group Title	Brand Name Travoprost First, Then Generic	Generic Travoprost First, Then Brand Name
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	38	38
COMPLETED	34	36
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Brand Name Travoprost First, Then Generic	Generic Travoprost First, Then Brand Name	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	34	36	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.32 (13.22)	68.53 (11.22)	67.50 (12.16)
Sex: Female, Male (Count of Participants)
Female	20 58.8%	12 33.3%	32 45.7%
Male	14 41.2%	24 66.7%	38 54.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 2.8%	1 1.4%
White	34 100%	35 97.2%	69 98.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	34 100%	36 100%	70 100%
Baseline intraocular pressure (mm Hg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mm Hg]	26.25	23.50	24.50
Mean deviation on visual field testing (decibels) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [decibels]	-1.12	-2.05	-1.66
Number of Treatment Naive Participants (Count of Participants)
Count of Participants [Participants]	28 82.4%	30 83.3%	58 82.9%
Diagnosis (Count of Participants)
Primary open angle glaucoma	27 79.4%	26 72.2%	53 75.7%
Ocular hypertension	7 20.6%	6 16.7%	13 18.6%
Normal tension glaucoma	0 0%	4 11.1%	4 5.7%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure
Time Frame	After 3 weeks of either the brand name or generic travoprost

Outcome Measure Data

Analysis Population Description

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/Group Title	Brand Name Travoprost	Generic Travoprost
Arm/Group Description	Participants who received Brand Name Travoprost one drop once daily in either the first or last 3 weeks of the study.	Participants who received Generic Travoprost one drop once daily in either the first or last 3 weeks of the study.
Measure Participants	70	70
Mean (Standard Deviation) [mm Hg]	18.20 (3.41)	18.44 (3.48)

2. Secondary Outcome

Title	Comfort and Intolerance to the Drops Questionnaire
Description	Patients will be asked about: Difficulties related to administration of the drops Compliance to the drops 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

Outcome Measure Data

Analysis Population Description

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/Group Title	Brand Name Travoprost	Generic Travoprost
Arm/Group Description	Participants who received Brand Name Travoprost one drop once daily in either the first or last 3 weeks of the study.	Participants who received Generic Travoprost one drop once daily in either the first or last 3 weeks of the study.
Measure Participants	70	70
Severe	0 0%	6 16.7%
Mild	5 14.7%	5 13.9%
Absent	65 191.2%	59 163.9%
Severe	4 11.8%	3 8.3%
Mild	13 38.2%	16 44.4%
Absent	53 155.9%	51 141.7%
Severe	1 2.9%	0 0%
Mild	13 38.2%	12 33.3%
Absent	56 164.7%	58 161.1%
Severe	8 23.5%	8 22.2%
Mild	16 47.1%	20 55.6%
Absent	46 135.3%	42 116.7%
Severe	4 11.8%	3 8.3%
Mild	7 20.6%	10 27.8%
Absent	59 173.5%	57 158.3%
Severe	1 2.9%	2 5.6%
Mild	10 29.4%	10 27.8%
Absent	59 173.5%	58 161.1%
Severe	3 8.8%	0 0%
Mild	4 11.8%	7 19.4%
Absent	63 185.3%	63 175%
Severe	4 11.8%	0 0%
Mild	22 64.7%	27 75%
Absent	44 129.4%	43 119.4%
Severe	0 0%	0 0%
Mild	1 2.9%	1 2.8%
Absent	69 202.9%	69 191.7%

Adverse Events

Time Frame	Three weeks for each intervention.
Adverse Event Reporting Description	Safety Population included all participants who received at least one dose of intervention.
Arm/Group Title	Brand Name Travoprost		Generic Travoprost
Arm/Group Description	Participants received Brand Name Travoprost one drop once daily for 3 weeks.		Participants received Generic Travoprost one drop once daily for 3 weeks.
All Cause Mortality
	Brand Name Travoprost		Generic Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)
Serious Adverse Events
	Brand Name Travoprost		Generic Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)
Other (Not Including Serious) Adverse Events
	Brand Name Travoprost		Generic Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/76 (1.3%)		0/76 (0%)
Eye disorders
Transient blurry vision	1/76 (1.3%)	1	0/76 (0%)	0
Vascular disorders
Hypertension	1/76 (1.3%)	1	0/76 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.