Glaucoma, Open AnglePhase 4NCT00804648
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 4 study testing Timolol Maleate in Sorbate, Timolol hemihydrate and Timolol maleate gel forming solution in people with Glaucoma, Open Angle and Ocular Hypertension, run by Vistakon Pharmaceuticals at 2 sites in United States.
Trial summary
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, Open Angle, Ocular Hypertension
- What is being tested?
- Timolol Maleate in Sorbate, Timolol hemihydrate and Timolol maleate gel forming solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing to comply with investigator's and protocol's instructions
- patients signature on the informed consent document
- primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
- at screening intraocular pressure must be considered to be safe, in both eyes
- in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
- currently treated with one glaucoma medication, untreated intraocular pressure of less than or equal to 28 mm Hg at visit 2 in both eyes
Who cannot join
- any abnormality preventing reliable applanation tonometry in either eye
- any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
- any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
- any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- females of childbearing potential not using reliable means of birth control
- pregnant or lactating females
Show all 17Show fewer
- any clinically significant, serious, or severe medical or psychiatric condition
- participation (or current participation) in any investigational drug or device trial within 30 days prior to Visit 1
- severe prior visual acuity or field loss from any cause
- inability to understand the trial procedures, and thus inability to give informed consent
- progressive retinal or optic nerve disease apart from glaucoma
- serious systemic or ocular disease
- intraocular laser surgery within the past three months or corneal or intraocular conventional surgery within the past 6 months
- concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic route.
- subjects requiring tear replacement drops or allergy medications with sympathomimetics 24 hours prior to a scheduled study visit
- contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
- any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Bourbonnais, Illinois
Study site
Charlotte, North Carolina
About this study
Official title: Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
- Conditions
- Glaucoma, Open Angle, Ocular Hypertension
- Being tested
- Timolol Maleate in Sorbate, Timolol hemihydrate, Timolol maleate gel forming solution
- 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.
Timolol Maleate in SorbateDrug
0.5%
Timolol hemihydrateDrug
0.5%
Timolol maleate gel forming solutionDrug
0.5%
| Study group | Role | What they receive |
|---|---|---|
| hemihydrate/maleate/maleate gel | Active comparator | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
| maleate/maleate gel/hemihydrate | Active comparator | Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
| maleate gel/hemihydrate/maleate | Active comparator | Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
| hemihydrate/maleate gel/maleate | Active comparator | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
| maleate/hemihydrate/maleate gel | Active comparator | Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
| maleate gel, maleate, hemihydrate | Active comparator | Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% Receives: Drug: Timolol Maleate in Sorbate; Drug: Timolol hemihydrate; Drug: Timolol maleate gel forming solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stinging on Instillation
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
Measured: following 3 days of treatment
Secondary outcomes (11)
Conjunctival Hyperemia
Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.
Measured: following 3 days of treatment
Tear Film Break-up Time
Measured: following 3 days of treatment
Corneal Staining Grade
Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.
Measured: following 3 days of treatment
Corneal Staining Count
Assessed by the investigator using a slit lamp, counting the number of spots.
Measured: following 3 days of treatment
Intraoclular Pressure
Measured: following 3 days of treatment
Basic Schirmer's
Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Measured: following 3 days of treatment
Conjunctival Staining - Nasal Grade
Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
Measured: following 3 days of treatment
Conjunctival Staining - Nasal Count
Assessed by investigator using slit lamp and counting number of spots.
Measured: following 3 days of treatment
Conjunctival Staining - Temporal Grade
Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
Measured: following 3 days of treatment
Conjunctival Staining - Temporal Count
Assessed by investigator using a slit lamp and counting number of spots.
Measured: following 3 days of treatment
Visual Acuity
The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.
Measured: following 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glaucoma, Open AngleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William C. Stewart, MD, Study director, PRN Pharmacuetical Research Network, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804648
- Sponsor's protocol ID
- VPH0111
- Status last verified
- Feb 2015
- First submitted
- 5 Dec 2008
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00804648
- Acronym / sponsor ID
- VPH0111
- Conditions
- Glaucoma, Open Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 20 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| hemihydrate/maleate/maleate gel | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% |
| maleate/maleate gel/hemihydrate | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% |
| maleate gel/hemihydrate/maleate | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% |
| hemihydrate/maleate gel/maleate | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% |
| maleate/hemihydrate/maleate gel | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% |
| maleate gel, maleate, hemihydrate | Active comparator | Drug: Timolol Maleate in Sorbate, Drug: Timolol hemihydrate, Drug: Timolol maleate gel forming solutionPeriod 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- willing to comply with investigator's and protocol's instructions
- patients signature on the informed consent document
- primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
- at screening intraocular pressure must be considered to be safe, in both eyes
- in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
Key exclusion criteria (17 listed)
- any abnormality preventing reliable applanation tonometry in either eye
- any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
- any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
- any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- females of childbearing potential not using reliable means of birth control
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 |
|---|---|---|
| Timolol Maleate in Sorbate0.5% | Drug | hemihydrate/maleate gel/maleate, hemihydrate/maleate/maleate gel, maleate gel, maleate, hemihydrate, maleate gel/hemihydrate/maleate, maleate/hemihydrate/maleate gel, maleate/maleate gel/hemihydrate |
| Timolol hemihydrate0.5% | Drug | hemihydrate/maleate gel/maleate, hemihydrate/maleate/maleate gel, maleate gel, maleate, hemihydrate, maleate gel/hemihydrate/maleate, maleate/hemihydrate/maleate gel, maleate/maleate gel/hemihydrate |
| Timolol maleate gel forming solution0.5% | Drug | hemihydrate/maleate gel/maleate, hemihydrate/maleate/maleate gel, maleate gel, maleate, hemihydrate, maleate gel/hemihydrate/maleate, maleate/hemihydrate/maleate gel, maleate/maleate gel/hemihydrate |
Primary outcome
Stinging on Instillation
Time frame: following 3 days of treatment
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
11 secondary outcomes
Conjunctival Hyperemia
Time frame: following 3 days of treatment
Tear Film Break-up Time
Time frame: following 3 days of treatment
Corneal Staining Grade
Time frame: following 3 days of treatment
Corneal Staining Count
Time frame: following 3 days of treatment
Intraoclular Pressure
Time frame: following 3 days of treatment
Basic Schirmer's
Time frame: following 3 days of treatment
Conjunctival Staining - Nasal Grade
Time frame: following 3 days of treatment
Conjunctival Staining - Nasal Count
Time frame: following 3 days of treatment
Conjunctival Staining - Temporal Grade
Time frame: following 3 days of treatment
Conjunctival Staining - Temporal Count
Time frame: following 3 days of treatment
Visual Acuity
Time frame: following 3 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William C. Stewart, MD study director
PRN Pharmacuetical Research Network, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timolol Maleate in Sorbate, Timolol hemihydrate and Timolol maleate gel forming solution in people with Glaucoma, Open Angle and Ocular Hypertension, run by Vistakon Pharmaceuticals at 2 sites in United States.
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 6 inclusion and 17 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stinging on Instillation (time frame: following 3 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.