A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-58
SponsorBausch & Lomb Incorporated

About this trial

This is a multicenter, double-masked study to evaluate the use of Topical Ocular BL1332 for the management of post-operative pain after Photorefractive Keratectomy (PRK) surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18 to 58 years of age, inclusive.

Scheduled to undergo PRK surgery and considered to be a good candidate per the Investigator's discretion.

Provide written informed consent (signed and dated informed consent form [ICF]) using the Institutional Review Board (IRB)-approved ICF prior to any study-related procedures.

Able to read, understand, and voluntarily sign the ICF and, if applicable, provide written authorization per local privacy regulations.

Disqualifiers

Women of childbearing potential or non-vasectomized males with partners of childbearing potential are not eligible unless they are using an effective method of contraception and agree to use an effective method of contraception until at least 30 days after study treatment.

Participation in a clinical trial within 30 days prior to Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Topical Ocular BL1332 low dose

    Drug

    Administered 5 times a day

  • Topical Ocular BL1332 high dose

    Drug

    Administered 5 times a day

  • BL1332 Vehicle ophthalmic vehicle

    Drug

    Administered 5 times a day

Treatment groups

123 Participants
are divided into 3 treatment groups
Group A: Topical Ocular BL1332 low doseExperimental treatment 1 intervention
Group B: Topical Ocular BL1332 high doseExperimental treatment 1 intervention
Group C: BL1332 ophthalmic vehiclePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ocular pain intensity following PRK surgery

Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain

Time frame
Assessed at a 24-hour period following PRK surgery

Secondary outcomes

1

Ocular pain intensity postoperative period following PRK surgery

Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain

Time frame
Assessed at a 12-hour postoperative period following PRK surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: