Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804648

Enrollment

Registered

2008-12-09

Start date

2008-11-30

Completion date

2008-12-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open Angle, Ocular Hypertension

Brief summary

This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.

Interventions

DRUGTimolol Maleate in Sorbate

0.5%

DRUGTimolol hemihydrate

0.5%

DRUGTimolol maleate gel forming solution

0.5%

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Stinging on Instillation	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.

Secondary

Measure	Time frame	Description
Tear Film Break-up Time	following 3 days of treatment	—
Corneal Staining Grade	following 3 days of treatment	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.
Corneal Staining Count	following 3 days of treatment	Assessed by the investigator using a slit lamp, counting the number of spots.
Intraoclular Pressure	following 3 days of treatment	—
Basic Schirmer's	following 3 days of treatment	Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Conjunctival Hyperemia	following 3 days of treatment	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.
Conjunctival Staining - Nasal Count	following 3 days of treatment	Assessed by investigator using slit lamp and counting number of spots.
Conjunctival Staining - Temporal Grade	following 3 days of treatment	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.
Conjunctival Staining - Temporal Count	following 3 days of treatment	Assessed by investigator using a slit lamp and counting number of spots.
Visual Acuity	following 3 days of treatment	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.
Conjunctival Staining - Nasal Grade	following 3 days of treatment	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall	30
Total	30

Baseline characteristics

Characteristic	Overall
Age, Continuous	66.3 years STANDARD_DEVIATION 8.9
Region of Enrollment United States	30 participants
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	2 / 30	2 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30	0 / 30

Outcome results

Primary

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.