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New eye drops could ease pain and swelling after cataract surgery

NCT ID NCT04130802

Symptom relief Sponsor: Oculis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial tested OCS-01 eye drops in 153 adults who had cataract surgery. The drops aim to reduce eye inflammation and pain. Participants received either a once-daily or twice-daily dose of OCS-01 or a placebo. The study measured how many people had no signs of inflammation or pain after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OCS-01 (dexamethasone cyclodextrin nanoparticle eye drops)
What this could lead to
If successful, this could provide a more effective and convenient eye drop option to manage pain and inflammation after cataract surgery.
What could go wrong
This is a Phase 2 trial with only 153 participants, so results may not hold up in larger studies. The treatment is compared to a placebo, not existing standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

153 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent, approved by the appropriate ethics committee; 2. Be able to comply with the study requirements and visit schedule; 3. Be at least 18 years of age of either sex or any race; 4. Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye; 5. Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post-uncomplicated cataract surgery without vitreous loss\]); 6. Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]); 7. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 \[prior to surgery\]), Exclusion Criteria: 1. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components; 2. Be monocular; 3. Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination; 4. Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye; 5. Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.

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Conditions

The condition(s) this trial relates to.

Inflammation keratitis Pain Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammation corneal Pain, postoperative

Contacts and locations

Locations

  • Medical cennre

    Petaluma, California, 94954, United States

  • Medical center

    Roseburg, Oregon, 97471, United States

  • Medical center

    Houston, Texas, 77008, United States

  • Medical center

    San Antonio, Texas, 78229, United States

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