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Completed

NCT Number: NCT01655758

24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension

This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Eye Clinic

Parma, 43100, Italy

About this study

(a) study design: Prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, OD chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details). (c) study drugs: Timolol and dorzolamide will be chosen as inflow drugs. The three prostaglandin analogues (PGA) Latanoprost, travoprost and bimatoprost will be chosen as outflow drugs. (d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days PGA1, 60 days washout, 60 days PGA2, 60 days washout, 60 days PGA3. Patients were assigned to the PGAs according to a sequence (L-T-B) randomly generated. Data will be collected at baseline and at the and of each study phase (i.e. active treatment and washout)(e) main efficacy outcome: change in the mean IOP (with respect to baseline) at the end of each study phase and change of IOP (with respect to baseline) at the different time points of the 24-hour phasing. IOP will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of Goldmann applanation tonometry at the slit lamp. At midnight, 2 a.m. and 6 a.m. the Tonopen in supine position will be used. (f) statistics: the analysis of co-variance (ANCOVA) for paired samples with Bonferroni correction will be adopted. A minimum sample size of 51 patients is needed for a minimal expected difference in mean IOP between inflow and outflow drugs = 2.5 mmHg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IOP > 22 mmHg and < 30 mmHg on at least three readings on separate days ,
  • Open angle on gonioscopy,
  • CCT > 550 m,
  • optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
  • normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
  • Age > 40 and < 70 years,
  • refraction between - 5 and + 2 dyopters,
  • best corrected visual acuity better than 0.2 LogMAR,

Exclusion criteria

  • PEX
  • PDS
  • ocular comorbidiities other than refractive problems and/or mild dry eye
  • history of diabetes
  • treatment with systemic beta blockers and steroids
  • previous treatment with ocular hypotensive drugs

Treatment and study plan

0.5% timolol

Drug

Other names: timoptol (MSD)

timolol-dorzolamide fixed combination

Drug

Other names: cosopt (MSD)

latanoprost

Drug

Other names: xalatan (pfizer)

Travoprost

Drug

Other names: travatan (Alcon)

Bimatoprost

Drug

Other names: lumigan (Allergan)

Primary outcomes

  1. change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline

    Time frame: IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.

    Goldmann Applanation tonometry (GAT): 2 readings averaged. If >2 mmHg difference between the two, a further reading will be performed. GAT will be adopted during the day, and performed at the slit lamp in sitting position.

    Tonopen: 4 readings averaged. Tonopen will be used during the night, and the measurements will be perfomred on patients laying in bed in supine position.

Secondary outcomes

  1. visual field

    Time frame: visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)

    Humphrey Field Analyzer, 24/2 SITA standard

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

The 24 Control of IOP in Ocular Hypertension: a Cross-over Study on Inflow Versus Outflow Drugs.

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Aug 2, 2012
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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