Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
#529
Study information
Scientific title
Randomised, parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma
Acronym
Carteolol
Study hypothesis
In this study the hypothesis will be tested that a 3-month treatment with Carteolol is superior
to a 3-month treatment with Timolol in the subjective tolerance (ocular discomfort) upon
instillation.
Ocular hypertension or Primary Open Angle Glaucoma (POAG) (superiority design)
Ethics approval
1. Belgium (Lead Centre): Ethics Committee of UZ Leuven (KUL) approved on the 10th of April 2008 (ref: ML 4750)
2. Czech Republic: Local ethics committee (Eticke Komise) approved on the 17th of January 2008 (refs: protocol UtCIV; approval no. 1743107S-MEK)
3. France: Local ethics committee (Comité de protection des personnes Sud Est 6) approved on the 2nd of November 2007 (ref: AU 714)
4. Poland: Local ethics committee (Komisja Bioethyczna) approved on the 6th of January 2007 (ref: KB-517/2007)
5. Portugal: National Ethics Committee for Clinical Investigation (CEIC) approved on the 19th of May 2008 (ref: 0804AU135)
Study design
Investigator-masked parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Unilateral or bilateral ocular hypertension; Primary Open Angle Glaucoma (POAG)
Intervention
Written informed consent was obtained at baseline visit 1 (day 0). Eligibility was determined by reviewing medical history, recording of concomitant medication, external eye examination (signs of inflammation on eye lids, lid closure, lid motility, bulbar motility, conjunctival injection), and a check of inclusion and exclusion criteria.
Eligible patients were randomised to receive either
1. Carteolol LA 2%: Daily, 1 drop at 8 AM in the eye(s) to be treated over 3 months
2. Timolol LA 0.5%: Daily, 1 drop at 8 AM in the eye(s) to be treated over 3 months
Patients received the appropriate medication and diary card.
Follow up visits were carried out on days 30 and 90 (± 3 days). Further medication and diary cards were distributed on day 30 only. Used and unused bottles and diary cards were collected at both visits. Patients were not followed up beyond the end of the intervention period.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Evaluation of the subjective tolerance upon instillation (rate of patients experiencing symptoms of discomfort), graded as very good, good, bad or very bad, measured at baseline, 1 and 3 months
Secondary outcome measures
1. Assessment of each of the symptoms of the Glaucoma Symptom
Scale [15] (Yes/ No): burning/smarting/stinging, tearing, dryness, itching, soreness/tiredness, feeling of something in the eye, blurry/dim vision, hard to see in daylight, hard to see in dark places and halos around the light (for those who report a given symptom, a bothersome scale will be used: very, somewhat, a little, not at all)
2. Slit lamp examination (examination of conjunctiva, cornea, iris, lens, anterior chamber), performed at baseline, 1 and 3 months
3. Tear-film-break-up-time-test (BUT-test; sec), performed at baseline, 1 and 3 months
4. Fluorescein staining of the cornea, performed at baseline, 1 and 3 months
5. Van Bijsterveld test (Lissamine green), performed at baseline, 1 and 3 months
6. IOP measured at 12 PM (+/- 30mn), measured at baseline, 1 and 3 months
7. Assessment of Visual acuity and visual field, measured at baseline (if no visual field performed during the previous 3 months) and at 3 months
8. Fundoscopy, performed at baseline, 1 and 3 months
9. Adverse events, reported at 1 and 3 months
10. Compliance, reported at 1 and 3 months
Overall trial start date
11/12/2007
Overall trial end date
10/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients, men or women
2. Suffering from unilateral or bilateral ocular hypertension or POAG
3. Intraocular Pressure (IOP) controlled with beta-blocker monotherapy (IOP < 21mmHg and
visual field stable)
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
194
Participant exclusion criteria
1. Age < 18 years
2. IOP not controlled with beta-blocker monotherapy
3. Angle closure, congenital and secondary glaucoma
4. Any pathology contraindicating an IOP measurement
5. Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months
6. Previous intolerance to carteolol or timolol, or to any other ingredients of
the tested products
7. Beta-blocker contraindications
8. Ocular corticosteroids
9. Contact lens wearers
10. Severe systemic or ocular disease
11. Hypotension
12. Drug, alcohol abuse
13. Involvement in the last 30 days in any other investigational drug study
14. Expected change in treatment of concomitant disease
15. Patients with a history of recurrent ocular herpes and/or recurrent uveitis
16. Change in ocular treatment within the last month
17. Patients treated with other topical ocular treatment within the last month
18. Pregnant or lactating women
19. Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy
20. Patients for whom, in the physician's opinion, any of the protocol
procedures may pose a special risk not outweighed by the potential benefits of participating in the study
21. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period
22. Patients with neurotic, psychiatric disorders or suicidal tendencies
Recruitment start date
11/12/2007
Recruitment end date
10/08/2009
Locations
Countries of recruitment
Belgium, Czech Republic, France, Poland, Portugal
Trial participating centre
CHU de Clermont Ferrand Service
Cermont Ferrand
63000
France
Funders
Funder type
Industry
Funder name
Bausch & Lomb GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary