Phenylephrine vs Eyelid Taping for Drooping Eyelid

Overseen By Sara T Wester, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Ergot derivatives, MAO inhibitors

Disqualifiers: Pregnancy, Bradycardia, Hypotension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 60 minutes

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain drugs that should not be used with phenylephrine, like Ergot Derivatives, Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, or Monoamine Oxidase Inhibitors.

What data supports the effectiveness of the treatment for drooping eyelid?

The research shows that phenylephrine, a component of the treatment, is effective in dilating pupils, which suggests it can influence muscle activity in the eye area. This might indirectly support its potential effectiveness in treating drooping eyelids by temporarily improving muscle tone. ^{1 2 3 4 5}

Is phenylephrine safe for use in humans?

Phenylephrine is generally considered safe with few eye-related side effects, but it can cause serious heart-related issues like high blood pressure and stroke, especially in people with heart disease or high blood pressure. A lower concentration (2.5%) is recommended for eye exams and use in infants and the elderly, while a higher concentration (10%) should be used cautiously. ^{2 4 6 7 8}

How does the drug phenylephrine differ from other treatments for drooping eyelid?

Phenylephrine is unique because it works by stimulating the muscles in the eyelid to contract, which can help lift a drooping eyelid. Unlike surgical options, it is a non-invasive treatment that can be administered as eye drops, making it a convenient and quick option for temporary relief. ^{1 2 9 10 11}

What is the purpose of this trial?

This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.

Research Team

Sara T Wester, MD

Principal Investigator

University of Miami

Eligibility Criteria

Adults aged 18-90 with drooping eyelids (ptosis) who are evaluating surgery for this condition can join. They must understand the study, be able to do a visual field test, and not have allergies to phenylephrine eye drops. People taking certain drugs like Ergot derivatives or with specific heart conditions cannot participate.

Inclusion Criteria

I am being evaluated for a specific eyelid surgery due to droopy eyelids.

I can use eye-drop medications without any issues.

I am not allergic to phenylephrine eye drops.

Exclusion Criteria

I cannot use certain eye drops due to my heart or blood pressure conditions.

I am unable to give consent for medical procedures.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo superior visual field testing with eyelid taping and Phenylephrine 2.5% ophthalmic solution

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Eyelid Tape
• Phenylephrine Ophthalmic

Trial Overview The trial is testing if Phenylephrine eye drops are better than using tape to lift the eyelid for assessing how much ptosis blocks vision before eyelid surgery. Participants will try both methods so researchers can compare which predicts surgical outcomes best.

Participant Groups

Group I: Phenylephrine and Eye Taping Group Experimental Treatment 2 Interventions

Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

In a pooled analysis of 131 subjects from two Phase III trials, the fixed-combination mydriatic TR-PH showed significantly greater pupil dilation compared to its individual components (tropicamide and phenylephrine) and placebo, with changes of 0.58 mm, 3.87 mm, and 4.65 mm respectively (all p < 0.0001).

The treatment was found to be safe and well-tolerated, with adverse events being infrequent, transient, and mostly mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials. Wirta, DL., Walters, TR., Flynn, WJ., et al.[2021]

Mydriasert, an ophthalmic insert containing tropicamide and phenylephrine, provides adequate mydriasis for retinal angiography in both diabetic and nondiabetic patients, with similar efficacy to traditional eyedrops.

The use of Mydriasert is associated with a lower total drug dose, which may reduce the risk of cardiovascular side effects, while no severe adverse effects were observed in either treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and safety of the ophthalmic insert Mydriasert in patients undergoing retinal angiography. Cagini, C., Caricato, A., Tosi, G., et al.[2017]

The ophthalmic insert Mydriasert (MY) demonstrated superior pupil dilation compared to phenylephrine and tropicamide (PT) eye drops at 90 minutes, making it an effective option for mydriasis.

While MY took longer to achieve maximal dilation than PT drops, it provided comparable dilation levels during cataract surgery, indicating its safety and efficacy as an alternative method for pupil dilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study measuring the dilatory effect of a mydriatic device (Mydriasert(®)) versus topical drops. Saenz-de-Viteri, M., Fernández-Robredo, P., de Nova, E., et al.[2022]

In a study of 60 patients with primary open-angle glaucoma undergoing cataract surgery, Mydrane® provided stable pupil dilation comparable to Mydriasert® and topical eye drops, indicating its effectiveness as a mydriatic agent.

All three methods of pupil dilation resulted in similar surgery durations and maintained stable anterior chamber configurations postoperatively, suggesting that Mydrane® is a safe and effective option for facilitating cataract extraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the intracamerally administered mydriatics for cataract surgery in patients with primary open-angle glaucoma. Ripa, M., Cuffaro, G., Savastano, MC., et al.[2023]

The TPD ophthalmic solution, which combines tropicamide, phenylephrine, and diclofenac, effectively maintains pupil dilation (mydriasis) during cataract surgery, showing similar results to the standard T, P, and D solution.

In a study involving 25 eyes from 19 patients, both solutions resulted in comparable pupil diameters before and after surgery, indicating that TPD is as effective as the traditional combination for facilitating the surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[TPD ophthalmic solution (mixture of tropicamide, phenylephrine hydrochloride, and diclofenac sodium) for cataract surgery]. Hirowatari, T., Tokuda, K., Kamei, Y., et al.[2015]

Phenylephrine hydrochloride is an effective and relatively safe drug for ophthalmic use, but caution is advised due to potential severe cardiovascular side effects, especially in patients with pre-existing conditions like cardiac disease or hypertension.

The 2.5% concentration of phenylephrine is generally safe for use in infants and the elderly, while the 10% concentration should be used carefully and is contraindicated in patients with narrow-angle glaucoma or those on certain antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3. Phenylephrine hydrochloride. Meyer, SM., Fraunfelder, FT.[2019]

In a phase 3 study involving 758 adults with dry eye disease, OC-01 nasal spray significantly improved tear production compared to a placebo, with 47.3% and 49.2% of patients in the OC-01 treatment groups achieving a 10-mm improvement in Schirmer test scores at week 4.

OC-01 was well tolerated, with most treatment-emergent adverse events being mild and nonocular, although a higher percentage of patients in the OC-01 groups reported side effects compared to the vehicle group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. Wirta, D., Vollmer, P., Paauw, J., et al.[2022]

Dipivefrin (Propine) is effective in lowering eye pressure in glaucoma patients, but it has been associated with a high incidence of follicular conjunctivitis, leading to discomfort in some cases.

Withdrawal of dipivefrin typically resolves the conjunctivitis, but symptoms may return with other similar medications, highlighting the need for regular eye examinations to catch this side effect early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follicular conjunctivitis on Dipivefrin therapy for glaucoma. Coleiro, JA., Sigurdsson, H., Lockyer, JA.[2013]

In a study of 100 diabetic patients with darkly pigmented irides, 10% phenylephrine was found to be significantly more effective than 2.5% phenylephrine for achieving pupil dilation, with mean pupil diameters of 7.40 mm versus 7.05 mm respectively.

Despite the increased efficacy of 10% phenylephrine, there were no significant differences in heart rate or blood pressure between the two concentrations, suggesting that while 10% is more effective, the 2.5% concentration may be safer for patients with significant vascular disease or autonomic dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. Suwan-Apichon, O., Ratanapakorn, T., Panjaphongse, R., et al.[2013]

The novel phenylacetyl ester derivative of phenylephrone demonstrated a stronger mydriatic effect than phenylephrine and was effective without causing irritation to the rabbit eye, indicating its potential as a safe short-term eye treatment.

Unlike phenylephrine, which showed systemic circulation after topical application, the phenylacetyl ester resulted in localized activity with no traces of phenylephrine in the bloodstream, suggesting a safer profile for ocular use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel site-specific chemical delivery system as a potential mydriatic agent: formation of phenylephrine in the iris-ciliary body from phenylephrone chemical delivery systems. Goskonda, VR., Ghandehari, H., Reddy, IK.[2019]

The oxazolidine prodrug of phenylephrine demonstrated equal mydriatic (pupil-dilating) activity to phenylephrine HCl but achieved maximum effect 60 minutes earlier, suggesting a faster onset of action.

Suspending the base form of phenylephrine in sesame oil resulted in greater mydriatic activity compared to equimolar concentrations of phenylephrine HCl, likely due to a pH change in tear fluids that enhances absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the ocular absorption of phenylephrine. Chien, DS., Schoenwald, RD.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and safety of the ophthalmic insert Mydriasert in patients undergoing retinal angiography. [2017]

3. China pubmed.ncbi.nlm.nih.gov

Comparative study measuring the dilatory effect of a mydriatic device (Mydriasert(®)) versus topical drops. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the intracamerally administered mydriatics for cataract surgery in patients with primary open-angle glaucoma. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

[TPD ophthalmic solution (mixture of tropicamide, phenylephrine hydrochloride, and diclofenac sodium) for cataract surgery]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

3. Phenylephrine hydrochloride. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Follicular conjunctivitis on Dipivefrin therapy for glaucoma. [2013]

9. Thailand pubmed.ncbi.nlm.nih.gov

2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Novel site-specific chemical delivery system as a potential mydriatic agent: formation of phenylephrine in the iris-ciliary body from phenylephrone chemical delivery systems. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Improving the ocular absorption of phenylephrine. [2019]