clinical
INFORMATION

frequently asked questions

Was a trial conducted between LUMIFY and currently available OTC redness reliever eye drops?
In a small phase II clinical study (n=68), brimonidine tartrate 0.025% showed a statistically significant difference in redness reduction compared to placebo and oxymetazoline 0.025%.
What % of benzalkonium chloride (BAK) preservative is in LUMIFY?
The majority of commercially available topical eye drops contain BAK. The concentration of BAK in LUMIFY is 0.01%, which is lower than the maximum 0.02% allowed by the FDA.
Were there any incidences of allergic reaction to low dose brimonidine tartrate?
No evidence of allergic reaction to LUMIFY was reported in clinical trials.
What types of patients/specialties would LUMIFY be good for?
LUMIFY is approved for redness relief due to minor eye irritations for adults and children 5 years of age and over. For children under 5 years of age: consult a doctor.
How will LUMIFY affect pupil dilation?
In clinical studies, LUMIFY had no impact on pupil dilation. LUMIFY does not have this warning on its label like many other redness relievers.
What is the difference between LUMIFY and current OTC redness relievers?
Other redness relievers are either alpha-1 or alpha-1/alpha-2 mixed receptor agonists which reduce redness by generalized constriction of both arterioles and venules, resulting in a potential restriction of blood and oxygen through the eye. Because of activity on the alpha-1 receptor, there is an increased risk for the side effects of rebound redness and loss of efficacy over time. LUMIFY is different. It is a selective alpha-2 receptor agonist which reduces redness by constricting the venule, alleviating the potential decrease of blood and oxygen through the eye, and with minimal to no activity on the alpha-1 receptor, has a low risk of redness rebound of loss of efficacy over time when used as directed.
Can LUMIFY be used to counteract rebound redness from other glaucoma treatments?
Although not tested or evaluated in clinical trials, there is no contraindication of LUMIFY with other drops. If using other ophthalmic products while using LUMIFY, wait at least 5 minutes between each product.
Was there an intraocular pressure (IOP) lowering effect?
In phase 3 clinical studies there was no statistically significant evidence of IOP lowering.
Does LUMIFY cause rebound redness and tachyphylaxis similar to other OTC redness relievers?
In clinical trials, participants using LUMIFY had a low incidence of rebound redness and no tachyphylaxis. These adverse events are believed to be due to activity on the alpha-1 adrenergic receptor. Unlike other OTC redness relievers, which are either selective alpha-1 AR agonists or mixed alpha-1/alpha-2 AR agonists, LUMIFY is a selective alpha-2 AR agonist with an alpha-1:alpha-2 affinity ratio of 1:1000 which minimizes the potential for these adverse events.
How long does LUMIFY last?
Up to 8 hours. In clinical trials, 79% of patients still showed a statistically significant difference at 8 hours.
How quickly does LUMIFY work?
In 1 minute. In clinical trials, 95% of patients showed a statistically significant difference at 1 minute.
What were the most common side effects in clinical trials?
In clinical trials, a small number of people reported either itching, foreign body sensation, tearing or pain which were temporary and mild to moderate in severity.
How often can my patients use LUMIFY?
Patients should be advised to instill one drop in each eye that needs it every 6-8 hours. Do not use more then 4 times a day. As with other OTC redness relievers, patients should stop use and ask a doctor if they experience eye pain, changes in vision, redness or irritation that worsens or lasts more than 72 hours (3 days).
How did LUMIFY obtain FDA approval?
LUMIFY has been authorized for distribution by the FDA after review of our clinical trial program, in which six clinical studies were conducted to evaluate the safety and effectiveness of LUMIFY (brimonidine tartrate, 0.025%) in relieving ocular redness.

Fast acting and long lasting efficacy1

LUMIFY is so effective at reducing redness, your patients can see the difference almost immediately.*

Purple Tear Drop Icon 95%

Reported significant
improvement
in just one minute

Purple Tear Drop Icon 79%

Maintained significant
redness reduction
at eight hours

Representative of mean pre-instillation score: 1.8

Representative of mean
pre-instillation
score: 1.8

Representative of mean 5 minute post-instillation score: 0.5

Representative of mean
5 minute
post-instillation: 0.5

*Simulation to reflect average clinical trial results.
Based on patient reported findings from Phase 3.

Low risk for tachyphylaxis or rebound hyperemia1

Phase III efficacy study2:

Study about Low Risk for Tachyphylaxis Or Rebound Hyperemia1

Overall, six clinical studies were conducted in over 600 patients to evaluate safety and efficacy,
with no evidence of allergic reactions reported.

1McLaurin E, Cavet ME, Gomes PJ, Ciolini JB. Brimonidine ophthalmic solution, 0.025% for reduction of ocular redness. Optom Vis Sci. 2018, in press. One reported case of rebound hyperemia in Phase III Safety Study. 2Phase III was a double-blinded, randomized, placebo controlled study. n=60.

See how LUMIFY works differently
LUMIFY is the only OTC
redness reliever that primarily
constricts the venule.
See How Lumify Works Differently Video
X

how lumify compares

LUMIFY is a unique, patented formulation that is the only a2-AR agonist to primarily constrict the venule.

 
Redness
Relief
Available
OTC
No
Rebound
Redness
#1 Doctor
Recommended
Patented
Formula
FDA -
approved
Fast acting
and long
lasting
efficacy
Tests
equally
well across
all age
groups
Clear Eyes
Original
  • Visine Original
  • Rohto Cool
  • Advanced Eye Relief
 
 
 
 
 
Visine Original
  • Clear Eyes Original
  • Rohto Cool
  • Advanced Eye Relief
 
 
 
 
 
Rohto Cool
  • Clear Eyes Original
  • Visine Original
  • Advanced Eye Relief
 
 
 
 
 
Advanced Eye
Relief
  • Clear Eyes Original
  • Visine Original
  • Rohto Cool
 
 
 
 
 

DRUG FACTS

Directions

Adults and children 5 years of age and over:

  • instill 1 drop in the affected eye(s) every 6-8 hours
  • do not use more than 4 times daily
  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Children under 5 years of age: consult a doctor

Ingredients

Active Ingredient: Brimonidine tartrate (0.025%)

Purpose: Redness reliever

Inactive ingredients:

benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Other Information

Store at 15° -25°C (59° -77°F)

Questions or comments?: Call 1-800-553-5340

Warnings

For external use only

Do not use

  • if solution changes color or becomes cloudy

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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