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Summary of Clinical Trial Results: Bimatoprost for Eye Pressure Control

For General Public Understanding

Overview

This clinical study was designed to explore better treatment options for adults with open-angle glaucoma or ocular hypertension. These eye conditions are both linked to elevated intraocular pressure, which can lead to optic nerve damage and vision loss if left untreated.

About the Condition

Open-angle glaucoma is the most common form of glaucoma and is caused by fluid buildup in the eye, leading to increased pressure and, over time, potential damage to the optic nerve.

Ocular hypertension also results from fluid accumulation in the eye, but unlike glaucoma, it does not initially cause nerve damage or vision loss. However, it increases the risk of developing glaucoma in the future.

What Was Studied

Researchers investigated the safety and effectiveness of two different doses of bimatoprost, a medication developed to reduce eye pressure over the long term without requiring daily use. Its performance was compared to timolol, a well-known treatment already approved for reducing eye pressure.

Study Design

• The clinical trial was a Phase 3, randomized study, conducted between December 2014 and July 2020 across 15 countries.
• A total of 528 adult participants were enrolled; 472 completed the trial, while 56 did not.
• The study was structured into four main phases: Screening, Washout, Treatment, and Extended Follow-Up.

Treatment Groups

Participants were randomly assigned to one of three groups using a computer-based system (randomization), ensuring each group was comparable:

• A higher dose of bimatoprost
• A lower dose of bimatoprost
• Timolol (standard treatment)

Key Findings

A significant portion of patients experienced side effects:

• 61.9% in the higher-dose bimatoprost group
• 48.0% in the lower-dose bimatoprost group
• 20.8% in the timolol group

Despite the difference in side effect rates, patients treated with bimatoprost (both doses) showed similar or better improvements in lowering intraocular pressure compared to those treated with timolol.

Why It Matters

This study provides valuable insights that may support the development of long-acting treatment alternatives for patients with glaucoma and ocular hypertension. The results highlight bimatoprost as a potential option for reducing the burden of daily eye drops while maintaining pressure control.

If You Participated

If you were part of this study and have questions regarding your care or treatment, please contact your study doctor or clinic team.

1. General Overview of the Clinical Study

Who Participated in the Trial?

This study enrolled 528 adult patients diagnosed with either open-angle glaucoma or ocular hypertension. Of these, 472 completed the full study, while 56 withdrew for various reasons. Participants included nearly equal numbers of men (49%) and women (51%), ranging in age from 19 to 90 years, with an average age of 62.6 years.

To qualify, participants had to have elevated eye pressure in both eyes due to glaucoma or ocular hypertension, and require medical treatment. When both eyes met eligibility criteria, the one with the higher intraocular pressure was chosen as the "study eye." All participants were required to discontinue their usual eye pressure medications before entering the treatment phase.

Patients were not eligible if they had previously participated in a bimatoprost-related Allergan study, or if they had other eye conditions that could affect their safety or interfere with the study's outcomes.

Which Treatment Was Evaluated?

The study focused on a medication called bimatoprost, delivered via a small implant placed inside the eye. This implant was inserted between the cornea (the transparent front part of the eye) and the iris (the colored part). Over time, the implant gradually dissolved, slowly releasing bimatoprost to lower intraocular pressure.

Study Structure

The trial was divided into four distinct phases:

Screening Period – Doctors evaluated patients to ensure they met all study requirements.

Washout Period – Patients stopped taking any current eye pressure-lowering medications.

Treatment Period – Patients were randomly assigned to one of three groups:

• Group 1 received a lower dose of bimatoprost and placebo drops in the study eye, plus timolol drops and a sham procedure in the other eye.
• Group 2 received a higher dose of bimatoprost and placebo drops in the study eye, plus timolol drops and a sham procedure in the other eye.
• Group 3 received only timolol drops in both eyes, alongside sham procedures (no actual implant).

Treatments were given at three timepoints: Day 1, Week 16, and Week 32.

Extended Follow-Up – After the final dose, patients continued to be monitored by study doctors to assess long-term results and any delayed side effects.

Study Timeline and Follow-Up

Participants in the study were closely monitored by doctors after receiving their final dose of bimatoprost or timolol. Before entering the treatment phase, all patients had to stop using any other eye pressure-lowering medications they were previously taking.

The study was structured into four main periods:

• Screening Period (28 days) – Participants were evaluated for eligibility.
• Washout Period (42 days) – Previous treatments were discontinued to ensure a clear baseline.
• Treatment Period (52 weeks) – Participants received their assigned medications.
• Extended Follow-Up (12 months) – Patients were monitored after completing treatment.

Treatment Groups

Participants were randomly assigned to one of the following three groups:

• Group 1: Lower dose bimatoprost in one eye with placebo drops, and a sham procedure plus timolol in the other eye.
• Group 2: Higher dose bimatoprost in one eye with placebo drops, and a sham procedure plus timolol in the other eye.
• Group 3: Sham procedure plus timolol drops in both eyes (no bimatoprost given).

Each participant received treatment on Day 1, Week 16, and Week 32.

Side Effects and Safety Findings

Side effects refer to any unwanted medical issues that may be related to the treatment. These effects were monitored carefully by study doctors. A side effect is considered serious if it results in hospitalization, is life-threatening, causes long-term disability, or leads to death.

Serious Side Effects:

• 6.3% of patients (11 people) in the higher-dose bimatoprost group had serious side effects.
• 2.9% (5 patients) in the lower-dose bimatoprost group reported serious side effects.
• 0% in the timolol group had any serious side effects.
• No deaths were reported during the study.

Stopping Treatment Due to Side Effects:

• 9.1% (16 patients) in the higher-dose group stopped treatment early.
• 2.3% (4 patients) in the lower-dose group did the same.
• Only 1.2% (2 patients) in the timolol group stopped treatment for this reason.

Overall Side Effects:

• 61.9% of patients (109) in the higher-dose bimatoprost group had at least one side effect.
• 48.0% (84 patients) in the lower-dose group experienced side effects.
• 20.8% (36 patients) in the timolol group reported any side effects.

The most common side effects were increased blood flow to the eye and loss of corneal cells. Patients in the higher-dose group generally experienced more side effects than those in the other groups.

Study Outcomes

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The clinical trial was completed as planned and confirmed that bimatoprost effectively reduces eye pressure in patients with open-angle glaucoma or ocular hypertension. From the start of treatment through Week 2, Week 6, and Week 12, both doses of bimatoprost showed results that were comparable to, or better than, timolol.

While the higher dose was linked to a higher rate of side effects, the overall ability to reduce eye pressure was consistent across both bimatoprost groups.

Why This Study Matters

The findings from this study have helped researchers better understand how bimatoprost can be used to manage eye pressure in people with glaucoma and ocular hypertension. The treatment offers a long-acting option that may reduce or eliminate the need for daily eye drops.

Although these results apply specifically to this clinical trial, they can serve as a foundation for future studies. Researchers may continue building on this work to explore new ways to improve care for people with these eye conditions.