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The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

NCT03139708 — Phase 1, Completed, 5 participants, Wake Forest University Health Sciences

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The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

RegistryNCT03139708
StatusCompleted
PhasePhase 1
Study typeInterventional; non randomized, parallel, masking: single, prevention
Enrollment5 (Actual)
SponsorWake Forest University Health Sciences (Other)
ConditionsIntraocular Pressure
InterventionsAlphagan, Phenylephrine, Tropicamide (Drug)
Datesstart 2016-09-01, primary completion 2017-10-01, completion 2017-10-01, first posted 2017-05-04, last updated 2018-08-09
Locations1 site in United States

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-Summary

This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.

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+Detailed description

Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.

+Arms and interventions

ArmTypeInterventionsDescription
Alphagan plusExperimentalDrug: Alphagan; Drug: Phenylephrine; Drug: TropicamideAlphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Tropicamide and Phenylephrine plusExperimentalDrug: Alphagan; Drug: Phenylephrine; Drug: TropicamideTropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Tropicamide and Phenylephrine onlyActive comparatorDrug: Phenylephrine; Drug: TropicamideTropicamide and Phenylephrine only arm is given one drop of each times one.
  • Alphagan (Drug), also known as Brimonidine: Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
  • Phenylephrine (Drug): Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.
  • Tropicamide (Drug): Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.

+Outcome measures

Primary outcomes

  • Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. [5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.]: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

Secondary outcomes

  • Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. [5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.]: Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. The investigator will measure the pupils under bright light conditions (photopic) and dim light conditions (scotopic)
  • Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours. [5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.]: Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. Pupil reaction will be measure either as none, poor, or brisk.

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study

Exclusion Criteria:

* Diabetic, history of glaucoma
* history of iris trauma
* history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
* Anisocoria
* pregnancy

+Locations (1)

FacilityCityCountryStatus
Wake Forest Baptist Health Eye CenterWinston-Salem, North CarolinaUnited States

+Investigators

  • Keith Walter, MD, Principal investigator, Wake Forest University Health Sciences

My Notes