Open Angle GlaucomaPhase 3NCT00878917
Equivalence Study of Dorzolamide 2% Eye Drops Solution
A Phase 3 study testing Dorzolamide 2 % eye drops solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alfred E. Tiefenbacher (GmbH & Co. KG) at 1 site in Germany.
Trial summary
The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Dorzolamide 2 % eye drops solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of any race aged 18 years or older
- A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- IOP controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study
- Baseline IOP between 18 and 32 mmHg in the study eye (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
- Best corrected visual acuity of 20/200 or better in the study eye(s)
- Ability of subject to understand character and individual consequences of clinical trial
- Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- Women with childbearing potential have to practicing a medically accepted contraception during trial and a negative pregnancy test (serum or urine) should be existent before trial. Reliable contraception are systemic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicidal. Women that are sterile by surgery or for more than two years postmenopausal can be participate in the trial.
Who cannot join
- Chronic or recurrent inflammatory eye disease
- Ocular trauma within the past six months
- Current ocular infection, i.e. conjunctivitis or keratitis
- Any abnormality preventing reliable applanation tonometry
- Intraocular surgery or laser treatment within the past three months
- Inability to discontinue contact lens wear during the study
Show all 14Show fewer
- Use of any systemic medication that would affect IOP with less than a
- 1-month stable dosing regimen before the screening visit
- Pregnancy and lactation
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- Participation in other clinical trials during the present clinical trial or within the last four weeks
- Medical or psychological condition that would not permit completion of the trial or signing of informed consent
- Subject is allergic to sulfonamides
- Severe renal dysfunction or hyperchloraemic acidosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Opthalmology, Johannes-Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Dorzolamide 2% Eye Drops Solution In Subjects With Open Angle Glaucoma Or Ocular Hypertension
The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Dorzolamide 2 % eye drops solution
- Keywords
- Equivalence Study, Eye Drops Solution, Dorzolamide, Open Angle Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorzolamide 2 % eye drops solutionDrug
1 drop into eye(s) three times a day for the duration of each treatment phase
| Study group | Role | What they receive |
|---|---|---|
| Dorzolamide | Experimental | Not described Receives: Drug: Dorzolamide 2 % eye drops solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure (IOP)-lowering
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfred E. Tiefenbacher (GmbH & Co. KG)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Norbert Pfeiffer, Prof. Dr., Principal investigator, Department of Opthalmology, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878917
- Sponsor's protocol ID
- DOR/2008
- Status last verified
- Feb 2010
- First submitted
- 8 Apr 2009
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hurvitz LM, Kaufman PL, Robin AL, Weinreb RN, Crawford K, Shaw B. New developments in the drug treatment of glaucoma. Drugs. 1991 Apr;41(4):514-32. doi: 10.2165/00003495-199141040-00002.
PubMed 1711957Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44.
PubMed 12751655Bell K, Korb C, Butsch C, Giers BC, Beck A, Strzalkowska A, Ruckes C, Klingberg U, Pfeiffer N, Lorenz K. A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt(R) Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension. J Ophthalmol. 2022 Jul 20;2022:5249922. doi: 10.1155/2022/5249922. eCollection 2022.
PubMed 35909461
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Dorzolamide 2% Eye Drops Solution In Subjects With Open Angle Glaucoma Or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00878917
- Acronym / sponsor ID
- DOR/2008
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Equivalence Study, Eye Drops Solution, Dorzolamide, Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alfred E. Tiefenbacher (GmbH & Co. KG)Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dorzolamide | Experimental | Drug: Dorzolamide 2 % eye drops solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients of any race aged 18 years or older
- A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- IOP controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study
- Baseline IOP between 18 and 32 mmHg in the study eye (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
- Best corrected visual acuity of 20/200 or better in the study eye(s)
Key exclusion criteria (14 listed)
- Chronic or recurrent inflammatory eye disease
- Ocular trauma within the past six months
- Current ocular infection, i.e. conjunctivitis or keratitis
- Any abnormality preventing reliable applanation tonometry
- Intraocular surgery or laser treatment within the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorzolamide 2 % eye drops solution1 drop into eye(s) three times a day for the duration of each treatment phase | Drug | Dorzolamide |
Primary outcome
intraocular pressure (IOP)-lowering
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
- Background: PubMed 1711957Hurvitz LM, Kaufman PL, Robin AL, Weinreb RN, Crawford K, Shaw B. New developments in the drug treatment of glaucoma. Drugs. 1991 Apr;41(4):514-32. doi: 10.2165/00003495-199141040-00002.
- Background: PubMed 12751655Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44.
- Derived from this study: PubMed 35909461Bell K, Korb C, Butsch C, Giers BC, Beck A, Strzalkowska A, Ruckes C, Klingberg U, Pfeiffer N, Lorenz K. A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt(R) Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension. J Ophthalmol. 2022 Jul 20;2022:5249922. doi: 10.1155/2022/5249922. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Pfeiffer, Prof. Dr. principal investigator
Department of Opthalmology, Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dorzolamide 2 % eye drops solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alfred E. Tiefenbacher (GmbH & Co. KG) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (IOP)-lowering (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878917, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2010.